Quality Assurance in Charge

6 months ago

Makarpura Vadodara Gujarat, India sai placement Full time

**Responsibilities**:

- To prepare departmental work plan and to ensure that plan is executed effectively.
- To do resource planning for departmental functions.
- To manage(prepare,review, approve and retrive) GMP Documents like

SOPs,Protocols,Master Documents,Change Controls,Deviations, Incidents,Investigation,

Market Complaints, Audits and Compliance, Self-Inspections,Qualification,Validation and

Calibrations,Training Calendar)
- Review of batch documents for executed batches and to ensure timely releases of same.
- To prepare site for Regulatory and various customer audits.
- To ensure prevention of cross-contamination and mix-ups.
- To ensure management of artworks.
- To ensure Vendor Quality Assurance.
- To liase with local regulatory authorities as and when require.
- To ensure proper investigations for any failure or market complaints.
- To ensure that CAPA is generated and implemeted effectively.
- To ensure that controlled documentation is always maintained.
- To manage Stability Studies samples, testings and summary reports.
- To perform various Risk Assesment and mitigation of risks identified.
- To ensure preparation of APQRs in a timely manner and approval of same.
- To issue Quality Alerts as and when required.
- To ensure product recalls as and when required.
- To ensure investigation of returned goods.
- To monitor Contract Manufacturing Quality indicators.
- Retain Sample and Batch and non-batch related document Management.
- HMI,PLC and Software management where equipment are operated with same.
- To ensure pharmacopoeial compliance.
- Review and approval of Stability Studies reports and summary.
- Coordination with Regulatory Affairs for Quality related matters.
- To ensure URS-FAT-SAT-DQ-IQ-OQ and PQ of equipment/instruments/software-PLC-HMI.

**1) Educational Qualification :B. Pharm / M. Pharm OR B.Sc./M.Sc. ( Chemistry or Microbiology)**

**2) Experience : 5 to 7 years in a pharmaceutical company’s Quality Assurance**.

**Salary**: ₹300,000.00 - ₹500,000.00 per year

**Education**:

- Bachelor's (preferred)

**Experience**:

- 7 yeras: 5 years (required)

Ability to Commute:

- Makarpura, Vadodara, Gujarat (required)

Ability to Relocate:

- Makarpura, Vadodara, Gujarat: Relocate before starting work (required)

Work Location: In person

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