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:

- Perform routine inspection and verification of in-process activities in the manufacturing area.
- Monitor and verify handover activities of ARM (Active Raw Material) and bulk product.

Validation Activities:

- Oversee and monitor ongoing validation activities on the shop floor.
- Ensure compliance with validation protocols and GMP requirements.

Product Campaign Changeover:

- Verify and review product campaign changeover activities, ensuring cleanliness and compliance with SOPs.

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:

- Review batch production records for products manufactured.
- Verify and review analytical files of manufactured products.

Archiving:

- Archive master documents, including SOPs, specifications, production orders, batch records, and solution preparation records.
- Control and archive canceled, obsolete documents, and maintain organizational data backups.

Document Issuance:

- Issue and control production orders, batch records, SOPs, specifications, log sheets, logbooks, layouts, and other forms.

Document Control and Stamps:

- Oversee the control of stamps used in the QA documentation section.
- Ensure proper destruction of documents after shelf life completion.

Vendor Management

- Coordinate with the vendor management team to plan and execute vendor assessments and approvals.
- Maintain records of assessments and approvals for raw materials, packaging materials, testing animals, and service providers.

Training and Development

Training Programs:

- Develop and execute an annual cGMP training planner and individual training records.
- Impart training to new employees on SOPs related to the documentation section and aseptic practices.
- Conduct computer-based training sessions.

On-Job Training:

- Prepare, review, and authorize on-job training programs and reports for new joiners.

Archiving Training Records:

- Archive training records and maintain signature specimens of all employees.

Training Agenda:

- Create training agendas in line with the annual planner.

Competencies Required

Aseptic Handling Expertise:

- Deep understanding of aseptic behavior, handling, working, and cleaning processes critical to sterile operations.

Sterile Operations Knowledge:

- Comprehensive understanding of sterile operations, scientific practices, and process criticalities in vaccine manufacturing.

Analytical Skills:

- Strong in trend analysis, data evaluation, and process calculations.

Quality and Timely Deliverance:

- Deliver accurate and high-quality results within stipulated timeframes.