Purpose-Handling Change Controls, CAPA, investigations, Support in Audit and Compliance Management, Handling of QMS documentation

Position / Job Title-Sr. Executive

Department-Quality Assurance

Reporting To-AGM, Quality Assurance

Location-Ambernath

Years of Experience-6 to 7 Years

Dosage Form-Solid Oral/ Nasal

Job Responsibilities / Deliverables

- Handling change controls, CAPA and quality risk assessment documentation, including evaluation, action verification, effectiveness verification, progress tracking, and proper closure, as well as trending.
- Coordinating with cross-functional teams and performing impact assessments for proposed changes.
- Reviewing investigations and associated CAPAs.
- Performing data analysis and preparing presentations for weekly and monthly review meetings.
- Preparing and reviewing SOPs.
- Reviewing and evaluating QMS documents.
- Participating in customer and regulatory inspections.
- Participating in self-inspections.




- Auditing the internal quality system as part of self-inspections (internal audits).
- Escalating issues in a timely and proactive manner.

Qualifications & Pre-Requisites Must-Have Skills:

- B. Pharm/ M.

Pharm

With relevant experience in pharma quality assurance.

- Must have knowledge of handling Change Controls and CAPA.
- Exposure to various regulatory bodies such as US FDA, EU-GMP, MHRA, TGA.
- Exposure to specific dosage forms like OSD, Liquid Orals, Nasal (optional).
- Effective communication, Team coordination and work in collaboration within compliance

Additional Notes

- Role is expected to be worked in all shifts and all days of the week.
- Expected to visit Satara, Thane, Pithampur or other manufacturing sites on need basis and as per business requirements.

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