IPT Process Support Specialist

2 weeks ago

Delhi, Delhi, 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.

IPT Process Support Specialist

Job Purpose:


Responsible for generating and expediting review and approval processes for IPT GMP documentation including but not limited to Quality Notifications, CAPA close out records, IPT Standard Operating Procedures and Standard Work Instructions and change controls.

Ensure that objectives are effectively achieved, consistent with client's requirements to ensure compliance, safety and reliable supply to our customers.

Requirements

Principal Accountabilities:

  • Support manufacturing activities through documentation generation, equipment and process investigations associated with non-GMP activities and completion of quality notifications. Provide input to the MES development process team on technical aspects of MES functionality and serve as MES SME within IPT
  • Be a document system expert; this will include document review, approval and document system work flow expedition. Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so. Documents will include SOP's, SWI's, training documents, and change controls. Support operation activities through documentation generation, filing, tracking, auditing and efficient maintenance of all associated databases including the maintenance, auditing and archiving of the process documentation system.
  • Support Batch release through timely Quality Notification completion, Interim/summary report generation; meeting batch release requirements.
  • Raise CAPA's and conduct investigations. Raise and investigate quality notifications using standard tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why's etc.; implement subsequent corrective action through the change management system.
  • Complete Customer complaint investigations and Change Controls and ensure they are closed out to support production activities in a timely manner in conjunction with the SCM team.
  • Required to comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture
  • May be required to perform other duties as assigned.
  • Assist in the management and/or assignment of IPT training if required

Qualification:

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline


Typical Minimum Experience:

  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting

Core Competences:
Technical

  • SAP knowledge and experience required
  • Proficiency in Microsoft Office and job related computer applications required
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices
  • Report, standards, policy writing skills required
  • Equipment and process validation
  • Sterile filling processes and equipment
  • Lean Six Sigma Methodology experience desired

Business:

  • Excellent communication, presentation and interpersonal skills, to interface effectively with levels of colleagues and with external customers in a team orientated manner
  • Understand the specific responsibilities of all Carlow departments as they relate to ones department, understanding the business processes ones department supports
  • Strong team skills, including ability to coach/develop work teams
  • Excellent training, facilitation and assessment skills
  • Risk management skills
  • Strategy planning and development
  • Demonstrable analytical and systematic problem solving skills
  • Strong influencing skills
  • Flexible approach
  • Effective time management and multi-tasking skills
  • Proven organizational skills
  • Excellent attention to detail
  • Trouble shooting skills
  • Goal/results orientated

Leadership:

  • Focus on Customers and Patients
  • Collaborate
  • Act with Candor and Courage
  • Make Rapid, Disciplined Decisions
  • Drive Results
  • Build Talent
  • Demonstrate Ethics and Integrity

Reports to:
Operations Coach (Manufacturing Support)

Requirements

Qualification:

  • Bachelor's Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline


Typical Minimum Experience:

  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably GMP setting

  • Process Support Specialist

    2 weeks ago

    Delhi, Delhi, India PSC Biotech Ltd Full time

    Job DescriptionAbout 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...

  • Upstream Documentation Specialist

    2 weeks ago

    Delhi, Delhi, India PSC Biotech Ltd Full time

    Job DescriptionAbout 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...

  • Associate Quality Assurance Specialist

    2 weeks ago

    Delhi, Delhi, India PSC Biotech Ltd Full time

    Job DescriptionAbout 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...

  • Process Specialist

    2 weeks ago

    Delhi, Delhi, India Infosys BPM Full time

    We are hiring for Process Specialist - Insurance Underwriting Support for Mangalore Location.Job Description:Location: MangaloreQualification: Any GraduateExperience: Minimum 1 yearShift: Night ShiftPurpose of the role:Executes transactions as per the prescribed guidelines and timeliness and follows all predefined procedures with the objectives to meet SLA...

  • Process Engineer

    2 weeks ago

    Delhi, Delhi, India PSC Biotech Ltd Full time

    Job DescriptionAbout 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...

  • IT Support Specialist

    2 weeks ago

    Delhi, Delhi, India Agensi Pekerjaan BTC Sdn Bhd Full time

    Job DescriptionOpen Position: IT Support Specialist (Legal Firm)A Legal Firm company is currently hiringIT Support Specialistto join them in their Kuala Lumpur office.Key responsibilities include:Holds Bachelor's degree in Information Technology is preferred.Troubleshoots, diagnoses problems, implements corrective action procedures in other computer-related...

  • Customer Support Specialist

    2 weeks ago

    Delhi, Delhi, India Bottomline Full time

    Position Title: ​Customer Support Specialist ​Department: ​50300​ Reports To: ​Client Services Manager​FLSA:​Non-exempt​ Job Family: ​Administrative ​EEOC:​- Administrative Support Workers​Position Summary:The Paymode-X Customer Support Specialist position is a full-time permanent position. The majority of the Customer Support...

  • IT Support Specialist

    2 weeks ago

    Delhi, Delhi, India Norstella Full time

    Role IT Support SpecialistLocation India, Remote (Work from anywhere in India)Minimum Qualification B. Tech. (or equivalent) from an accredited institutionIndicative Experience 5+ yearsDomain Preferably life-sciences / pharmaCustomer Profile Captive research and development pods for a $ 500 million group of pharma data research companies that help patients...

  • IT support specialist

    2 weeks ago

    Delhi, Delhi, India Snaphunt Full time

    The OfferJoin a strongly-backed, fast growing B2B SaaS startupExcellent scope for growth & development while working in a regional teamThe JobYou will be responsible for :Providing technical support to end-users by diagnosing and resolving hardware and software issues.Responding to helpdesk tickets to support end-user system implementations, problem...

  • Support Specialist

    2 weeks ago

    Delhi, Delhi, India Globalization Partners. Full time

    As a Support Specialist, you will have responsibility for supporting customers and professionals throughout the region. You will be a part of our Support Team supporting HR, IT, Finance, and benefits queries. In this role, you will handle all day to day queries with resolution for all the in-scope verticals.What you can expect to do:Support Level 1 IT / HR...

  • Peer Support Specialist

    2 weeks ago

    Delhi, Delhi, India Parents Anonymous Full time

    Job DescriptionParents Anonymous Inc. is seeking qualified and passionate Peer Support Specialists to join our team for our new United Mental Health Promoters (UMHP) program in the wider Antelope Valley, California area. Take a moment to review the job requirements below and see if you're the perfect fit for this exciting opportunity.This position is fully...

  • Peer Support Specialist Trainer

    2 weeks ago

    Delhi, Delhi, India Parents Anonymous Full time

    Job DescriptionParents Anonymous Inc. to find a passionate candidate to fill theirMediCal Peer Support Specialist Trainer.This position does require you to be in the Los Angeles area. There are part-time and full-time positions available for this position.FT: up to 40 hours Per Week, Hourly, Schedule: Monday - Friday, 8:00am-5:00pmPT: up to 24 hours Per...

  • Software Support Specialist

    2 weeks ago

    Delhi, Delhi, India Flintex Consulting Pte Ltd Full time

    Job DescriptionThe Right Individual:The ideal candidate will be expected to provide technical support to organizations by managing, maintaining, and troubleshooting their IT systems. We are looking for a Software Support Specialist to assist our customers with technical problems when using our products and services. Your responsibilities include resolving...

  • IT Support Specialist

    2 weeks ago

    Delhi, Delhi, India Qubit Capital Full time

    Job DescriptionThis is a remote positionRole Overview:We are seeking an IT Support Specialist to manage our email infrastructure and provide comprehensive IT support. The ideal candidate is a proactive learner, eager to tackle new technologies and challenges, with experience in email infrastructure management and IT support, preferably in a fintech or...

  • IT Support Specialist

    2 weeks ago

    Delhi, Delhi, India Booth and Partners Pte Ltd Full time

    Job DescriptionAbout the Client:Peak Designmakes award-winning bags, camera accessories, and an ecosystem of rugged phone mounts. They design truly radical gear, unparalleled in thoughtfulness, and have managed to build an equally radical company in their 12+ years of doing business.They have zero outside investors, crowdfund massively ambitious products,...

  • HRIS Process Specialist – HR Shared Services

    2 weeks ago

    Delhi, Delhi, India Clean Harbors Full time

    Job Title:HRIS SME/Process Specialist: HR Shared ServicesShift Timings:5:30 PM – 02:30 AM IST. Willingness to work from the office and stretch when business requires.Role Brief:This is an HRIS SME/Process Specialist role, primarily to support our US & Canadian regions.Job Description:Process, maintain, & administer HR transactions & provide...

  • IT Sales Support Specialist

    2 weeks ago

    Delhi, Delhi, India SoftwarePac LLC Full time

    Position Overview:We are looking for a meticulous and proactive IT Sales Support Specialist with outstanding English language skills to join our dynamic sales team. The perfect candidate will be in charge of creating quotes, handling client outreach, and making calls to support our sales efforts. This position plays a crucial role in ensuring smooth...

  • Government Proposal/RFP Support Specialist

    2 weeks ago

    Delhi, Delhi, India Redolent, Inc Full time

    Exciting opportunity for an experiencedGovernment Proposal/RFP Support Specialist (USA)for ourIT Staffing and Solutions,to join one of the fastest growing companies in our space.Title: Government Proposal/RFP Support Specialist (USA)No of positions: 1Location: Remote,IndiaNotes:Experience in supporting Government Proposal Support for USA Federal, State and...

  • Customer Support Specialist

    2 weeks ago

    Delhi, Delhi, India Dawar Consulting, Inc. Full time

    Job DescriptionOur client, a world leader in life sciences and diagnostics, is looking forCustomer SupportSpecialist.Kindly have a look at the details below and let me know if you are interested.Job Title: Customer SupportSpecialist Indianapolis, INJob Duration:Long Term Contract(Possibility Of Extension)Company Benefits include:Healthcare (Medical, Dental,...

  • Peer Support Specialist

    2 weeks ago

    Delhi, Delhi, India Parents Anonymous Full time

    Job Description Parents Anonymous Inc. is searching for qualified and dedicated Peer Support Specialists to join the team for the new United Mental Health Promoters (UMHP) program in the broader Antelope Valley, California region. Take a moment to go over the job requirements below to see if you're the ideal match for this exciting opportunity. This role is...