Job Description

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.