QC Microbiology Analyst

3 weeks ago

india PSC Biotech Ltd Full time
Job Description
About PSC Biotech

 

 

Who we are?

 

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

 

 

‘Take your Career to a new Level’

 

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

 

  

Employee Value Proposition

 

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.


Job Title: QC Microbiology Analyst

 

Role Description:

·         The QC Microbiology Analyst role is a critically important activity to ensure efficient and effective compliant, qualification, and operation of the new strategic Drug Substance facility. This tremendous opportunity will be responsible for qualifying the Microbiology Quality Control lab and the verification of Microbiological analytical methods including but not limited to cutting edge Rapid Microbiological Methods. This person will be key in the layout of the lab testing flow to ensure the process is streamlined and in line with lean principles.

·         The candidate will provide support to other analysts within the lab area, including training and guidance on their area of expertise.

·         The full QC analytical scope will incorporate micro, raw materials, stability, and in-process.  Innovation and advanced analytical methods (rapid ID technics, paperless lab, etc.) will allow the candidate challenge current thinking in designing for the future. The candidate will have responsibilities in the qualification of methods.


Requirements

Role Functions:

·         Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements.

·         The motivation to be an inspiring member of a high performing team.

·         The desire to continuously learn, improve and develop.

·         Perform supportive activities for general lab readiness, laboratory equipment qualification and method qualifications.

·         To integrate and complete all documentation on time and be familiar with LIMS.

·         Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards.

·         Support the laboratory testing schedule to achieve an efficient QC system.

·         Receive and manage samples that come into the lab for testing.

·         Solution preparation, cleaning, routine equipment maintenance and system set-up

·         Writing and update of SOPs

·         Maintain good housekeeping and GLP within the laboratory.

·         Calibrate and maintain all designated laboratory instruments.

·         Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures.

·         Ensure training is current for all job functions performed.

·         Assist in training new analysts on routine procedures and practices.

·         Order stock and receive laboratory supplies.

·         Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.

·         Ensure that cGMP standards are maintained at all times.

·         Delivery of area performance to meet or exceed performance or quality goals.

·         Promote and participate in the implementation and maintenance of the relevant safety programmes.

Participate and comply with the client Quality Management System requirements.

·         Responsible for driving a culture of Continuous Improvement

 

Experience:

·         1-3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory

·         Experienced in testing as per the pharmacopeia’s.

·         Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.)

 

Skills:

·         Ability to respond to changing priorities.

·         Strong organisational skills

·         Good verbal and written communication skills

·         Excellent troubleshooting and problem-solving skills

·         Good attention to detail

·         Ability to think logically and be proactive.

·         Ability to work as part of a team and on own initiative in a constructive manner

·         Flexible and self-motivated

 

Qualifications & Education

·         Bachelor’s Degree qualification (Science/Quality/Technical)

·         Masters preferred.

·         Preference Lean Six Sigma


#LI-KV1


Requirements
Role Functions: · Perform and carry out a variety of routine microbiological analytical techniques including but not limited to environmental monitoring, WFI sampling & testing, growth promotion testing, TOC & Conductivity testing, in-process product testing, final product testing such as bioburden and both Kinetic turbidimetric and MCS rapid endotoxin testing in compliance with GMP requirements. · The motivation to be an inspiring member of a high performing team. · The desire to continuously learn, improve and develop. · Perform supportive activities for general lab readiness, laboratory equipment qualification and method qualifications. · To integrate and complete all documentation on time and be familiar with LIMS. · Follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations, and industry standards. · Support the laboratory testing schedule to achieve an efficient QC system. · Receive and manage samples that come into the lab for testing. · Solution preparation, cleaning, routine equipment maintenance and system set-up · Writing and update of SOPs · Maintain good housekeeping and GLP within the laboratory. · Calibrate and maintain all designated laboratory instruments. · Participate in risk assessments, inspections, audits, incident investigations, etc. and implement and follow-up on corrective / preventative measures. · Ensure training is current for all job functions performed. · Assist in training new analysts on routine procedures and practices. · Order stock and receive laboratory supplies. · Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations. · Ensure that cGMP standards are maintained at all times. · Delivery of area performance to meet or exceed performance or quality goals. · Promote and participate in the implementation and maintenance of the relevant safety programmes. Participate and comply with the client Quality Management System requirements. · Responsible for driving a culture of Continuous Improvement Experience: · 1-3 years industry experience with significant knowledge and experience working in a Microbiology Laboratory · Experienced in testing as per the pharmacopeia’s. · Working knowledge of QC Systems (eLogs, Electronic Lab Notebook, LIMS etc.) Skills: · Ability to respond to changing priorities. · Strong organisational skills · Good verbal and written communication skills · Excellent troubleshooting and problem-solving skills · Good attention to detail · Ability to think logically and be proactive. · Ability to work as part of a team and on own initiative in a constructive manner · Flexible and self-motivated Qualifications & Education · Bachelor’s Degree qualification (Science/Quality/Technical) · Masters preferred. · Preference Lean Six Sigma #LI-KV1

  • QC Senior Microbiology Analyst

    4 days ago

    india PSC Biotech Ltd Full time

    Job Description About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • QC Microbiology Technician

    5 days ago

    india PSC Biotech Ltd Full time

    Job Description About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Mgr, Quality Control

    6 days ago

    india Endo Full time

    Job Description Summary To manage 12-member team of analysts, senior analysts in QC - microbiology laboratory.To prepare plans, protocols, reports and to execute day to day operations in microbiology laboratory. Job Description To manage a team of analysts, senior analysts, trainees in QC - microbiology laboratory.To prepare plans, protocols, reports...

  • Mgr, Quality Control

    1 day ago

    india Par Formulations Full time

    Description To manage a team of analysts, senior analysts, trainees in QC - microbiology laboratory. To prepare plans, protocols, reports and to execute day to day operations in microbiology laboratory. Commitment to Diversity, Equity, and Inclusion: At Endo, our diversity unites and empowers us as One Team, and we are committed to...

  • QC Separations Analyst

    1 week ago

    india PSC Biotech Ltd Full time

    Job Description About PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • QC Micro

    3 weeks ago

    india Job Excel Full time

    Job Description Overseeing testing activities and ensuring compliance with regulatory requirements, particularly in formulation testing.You will be responsible for developing and implementing microbiological testing protocols, ensuring their alignment with regulatory standards and industry best practices, particularly in formulation analysis.Overseeing daily...

  • QC Bioanalytical Analyst

    2 weeks ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech Ltd Who we are? PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...

  • QC laboratory Specialist

    2 weeks ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech   Who we are?   PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management...

  • Quality Control Microbiologist

    3 days ago

    india Resil Chemicals Full time

    JOB DESCRIPTION: Setting up a lab as per microbiological requirements in pharmaceuticals. Sampling and performing microbial test on raw materials, intermediates. Packing material, finished pharmaceutical products Perform stability study as per ICH guidelines requirements. Ensure compliance with regulatory guidelines such as GMP, GLP and relevant...

  • QC Associate

    4 days ago

    india Kemin Industries Full time

    Overview Position Objective :  The objective of this position is executing the quality plan by testing of raw materials, finished products and packing materials to ensure supply of quality products to Kemin’s internal and external customers. Responsibilities Collect materials for testing as per the approved sampling plan ...

  • Validation Analyst

    3 weeks ago

    india Test Triangle Full time

    Job Description Role: Validation Analyst  Employment Type- TP Location – Ballydine, Ireland.  Primary & Secondary Skill Validation Analyst / Computer System Validation (CSV) JD (Detailed)    Preferred Skills: • Minimum 3-5 years’ experience in the Pharmaceutical industry or a similar operating environment, with a strong emphasis on Lab Systems....

  • Governance

    1 month ago

    India Diageo Full time

    Job Description: The purpose of the role is to inspect packaging materials received at units & market, analyze raw material intermediate blends & finished goods and report to quality head. The role also is responsible for supporting in audits and assisting in MIS report preparation. TYPICAL ROLE REQUIREMENTS Qualification: - Post Graduate caliber or...

  • Engineer - Senior QC Analyst (SQL and Azure Databricks) 4+year's

    1 week ago

    india MNC Client Full time

    Role - Senior QC Engineer Location - Bengaluru Skills - SQL, Coding, SQL Cursors, Databricks. Salary - 20 LPA 3+ years of experience in SQL coding practices and methodologies, inclusive of working knowledge of SQL cursors, coding automation Qualifications Minimum 3+ years of experience in QA Strong knowledge and experience with SQL and SQL Databricks...

  • Quality Analyst

    1 week ago

    india MYPulse.IO Private Limited Full time

    Job Description Required HC: 01• Process: Collection & Revenue Assurance• Primary Role of the Position: The QA/QC Collection will play a very important and critical role in auditing the Collection-Journey of processes, employees and system falling under the purview of Collection Skillset:• He / She will be responsible for producing detailed quality...

  • Technical Support Analyst

    1 month ago

    india PSC Biotech Ltd Full time

    Job Description About PSC Biotech   Who we are?  PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...

  • Quality Auditor/Analyst-Customer Service Voice Process

    7 days ago

    india Infosys BPM Full time

    Greetings from Infosys BPM Ltd., We are hiring Quality Auditors/Analysts for an International Voice Process at Pune. Job Description: Role Designation: Process Specialist (QA) Job Location: Hinjewadi, Pune Education Qualification: Any full-time graduation / Post Graduation Shifts: 24*7 rotational shifts Experience required: 3 to 4 years. Process:...

  • Decision Analyst II, US Commercial Decision Intelligence

    7 days ago

    india Bristol Myers Squibb Full time

    Summary: The Decision Analyst will play an instrumental role for BMS, as they will be responsible for applying advanced statistical analysis and optimization techniques to support data-driven decision-making processes. The Decision Analyst will develop and implement descriptive/explanatory models, decision support models, segmentation strategies, portfolio...

  • Strategic Pricing Analyst

    6 days ago

    india Fortrea Full time

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff...

  • Business Analyst- Senior

    13 hours ago

    india Novalink Solutions LLC Full time

    Job Description NC Department of Health and Human Services seeks a Senior Business Analyst/Technical Writer to support IT software development projects implemented by vendors and/or in-house development teams.Primary tasks include:• Identify and document stakeholders, data flows, and current and future state process flows.• Gather, document, validate,...

  • Senior Principal Architect

    3 weeks ago

    india Majesco Full time

    Our Purpose: At Majesco, we believe in connecting people and business to Insurance in ways that are Innovative, Hyper-Relevant, Compelling and Personal. We bring together the brightest minds to build the future of Insurance; a world where Insurance makes life and business easier, more connected, and better protected. If you are passionate about the power...