Executive - Quality Assurance

12 hours ago

Mahad, India Piramal Pharma Solutions Full time

Preparation and updation of Validation Master Plan (VMP)
- Preparation of Process validation, Computer system validation protocol and report.
- Preparation of product matrix and Cleaning Validation/verification protocol and Report.
- Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
- Preparation of area validation protocol and reports.
- Preparation and review of quality risk assessments.
- Review of calibration certificate (External/internal).
- Preparation, issuance, review & archival of BMR/BPR.
- Batch Record storage, retrieval & destruction.
- Preparation of APQR.
- Line Clearance for Manufacturing, Packing & Dispensing activity.
- Sampling of Bulk and Finished goods.
- Review of production records and Finished Goods verification.
- Online observation of process deviation and effective implementation of CAPA.
- Management of Change Control / CAPA / Incidences.
- Handling of Change Control and follow-up for the implementation of Changes.
- To coordinate & maintain change control, deviation records.
- Complaint handling.
- Preparation and updation of Q.A departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2
- To give training as per the Training schedule.
- To coordinate training program of the company along with HR, including on Job Training.
- Documentation Management as per SOP.
- To provide necessary documents / data required by CQA and as per customer’s requirement.
- Conduct, monitor and review of compliance of Self Inspection Program.
- Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
- Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
- Ensuring avoidance of breach of data integrity in area.
- Implementation of effective sanitation programme in area.
- Adherence to the requirements of EHS norms.
- Execution of various initiatives as are suggested by corporate functions.
- To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.

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