QC Separations Analyst

1 week 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.

POSITION SUMMARY:

This position is responsible for carrying out tasks and projects related to testing procedures, equipment and lab utilities as required by Good Manufacturing Practice (GMP).

Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner.

Requirements

GENERAL SCOPE OF RESPONSIBILITIES:

· Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products.

· Review and approval of laboratory test results.

· Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines.

· Executes validation, operation, maintenance, calibration and troubleshooting of equipment and it's associated software.

· Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use.

· Ensures that all testing is completed, reviewed and approved within agreed turnaround times.

· Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards.

· Trains other QC analysts in laboratory methods and procedures when required.

· Writes/updates and reviews TMs, SOPs and WIs as required.

· Writes and reviews invalid assays, non-conformances and deviations as required.

· Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba.

· Is an active member of the QC group and provide assistance with other group activities as required.

· Communicates relevant issues to the QC Team Leader promptly.

· Maintains and develops knowledge of analytical technology as well as cGMP standards.

SPECIFIC TESTING EXPERIENCE REQUIRED:

· HPLC

· Capillary Electrophoresis

· UPLC/Mass Spec (desirable)

KEY COMPETENCIES REQUIRED:

· Excellent interpersonal skills.

· Ability to operate as part of a team is critical.

· Excellent communication skills both written and verbal.

· Good knowledge of LIMS, Track wise and Electronic documentation systems.

· Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint

· Experience working in a high throughput laboratory environment.

· Excellent technical writing skills.

· Customer focus.

· Attention to detail.

· Strong problem-solving skills.

· Results and performance driven.

· Adaptable and flexible.

QUALIFICATIONS AND EXPERIENCE:

· BSc (Honors) in a scientific/technical discipline.

· A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry.

· Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory.

#LI-KV1

Requirements
GENERAL SCOPE OF RESPONSIBILITIES: · Achieves a high level of competency in laboratory methods and procedures to support in process and release testing of biotechnology products. · Review and approval of laboratory test results. · Performs analytical testing activities in relation to method validation and technical transfer activities to ensure that all methods meet ICH, USP and EP guidelines. · Executes validation, operation, maintenance, calibration and troubleshooting of equipment and it's associated software. · Write/executes reports and reviews IQ/OQ and PQ protocols to ensure that all relevant equipment is qualified for cGMP use. · Ensures that all testing is completed, reviewed and approved within agreed turnaround times. · Ensures QC activities are carried out in compliance with product license commitments, cGMP and company quality standards. · Trains other QC analysts in laboratory methods and procedures when required. · Writes/updates and reviews TMs, SOPs and WIs as required. · Writes and reviews invalid assays, non-conformances and deviations as required. · Actively participates in JSI lean initiatives such as Kaizen, 6S and Gemba. · Is an active member of the QC group and provide assistance with other group activities as required. · Communicates relevant issues to the QC Team Leader promptly. · Maintains and develops knowledge of analytical technology as well as cGMP standards. SPECIFIC TESTING EXPERIENCE REQUIRED: · HPLC · Capillary Electrophoresis · UPLC/Mass Spec (desirable) KEY COMPETENCIES REQUIRED: · Excellent interpersonal skills. · Ability to operate as part of a team is critical. · Excellent communication skills both written and verbal. · Good knowledge of LIMS, Track wise and Electronic documentation systems. · Good knowledge of Microsoft Office applications such as word, Excel, PowerPoint · Experience working in a high throughput laboratory environment. · Excellent technical writing skills. · Customer focus. · Attention to detail. · Strong problem-solving skills. · Results and performance driven. · Adaptable and flexible. QUALIFICATIONS AND EXPERIENCE: · BSc (Honors) in a scientific/technical discipline. · A minimum of 2 years' experience in a QC laboratory-testing environment within the biological and/or pharmaceutical industry. · Demonstrated knowledge and testing experience in an FDA/HPRA approved QC laboratory. #LI-KV1

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