Senior Scientific Officer

Position Title : Senior Scientific Officer / Scientific Officer-Quality Assurance -IPQA

Educational Qualification : M.Sc. - Microbiology / Biotechnology, B.Tech- Biotechnology,

Experience : 3 to 7 years

Job Summary :

Senior Scientific Officer- IPQA shall be responsible for ensuring the quality and efficacy of vaccine Drug Substance Plant, Lalru (Punjab). This position will be responsible for overseeing the Shop Floor Monitoring i.e. Inspection and Verification of Active Raw Material and Bulk Product, Validation activities on the shop floor, Product campaign changeover, Packing and dispatch, Sample Issuance, Batch Production records, Vendor Management, cGMP & Regulatory compliance etc.

Compliance with cGMP Guidelines

• Maintain updated knowledge of current Good Manufacturing Practices (cGMP) and ensure compliance in all QA activities.
• Support the organization in preparing for internal and external audits and assist with compliance reports.

Shop Floor Monitoring

Inspection and Verification :

Validation Activities :

Product Campaign Changeover :

Product Management

Packaging and Dispatch : Verify packaging and dispatch activities for final ARM / bulk materials.

Sample Issuance : Manage the issuance of cell banks, reference standards, retention samples, and stability samples.

Destruction and Maintenance : Verify product / intermediate product destruction processes. Oversee defrosting and preventive maintenance of deep freezers.

Documentation and Record Management

Batch Production Records :

Archiving :

Document Issuance :

Document Control and Stamps :

Vendor Management

Training and Development

Training Programs :

On-Job Training :

Archiving Training Records :

Training Agenda :

Competencies Required

Aseptic Handling Expertise :

Sterile Operations Knowledge :

Analytical Skills :

Quality and Timely Deliverance :