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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