About this role
Provide support to Quality Control Manager in managing QC activities related to Cleaning Validation, Computer System Validation and Annual PQR process. Major Responsibilities:
• Prepare PQR (product Quality Review) Annual plan and implement it in timely manner. • Collect PQR related data from all stakeholders, review and analyse data and prepare PQR report. • Share PQR findings / observations / trends with respective sections and Senior Management for appropriate CAPA/recommendation. • Cleaning Validation • Preparation of Cleaning Validation Master Plan (CVMP), protocols and reports with worst case selection as per recent guidelines and products at site. • To ensure Cleaning Validation activities related with Products, Processes, and Equipment. • To provide support to QC in conducting glassware cleaning validation. • Conduct Cleaning validation and revalidation via preparing cleaning validation protocols, relevant documentation as per Master plan. • Perform and manage cleaning validation sampling activities along with QA support. • Revision of cleaning validation schedule as per production and supply priority as per their request and consensus. • Computer System Validation: • Prepare annual Computer System Validation Master Plan (CSVMP) of QC equipment and ensure adherence, prepare, and communicate monthly computer system validation plan to all stake holders. • Prepare protocols and reports of computer system validation and to perform computer system validation activity accordingly. • General Responsibility: • Review of applicable policies and align SOPs (related to PQR, cleaning validation, and computer system validation). • Implementation and compliance of all the SOPs and applicable policies and procedures. • To review and complete change control tasks with respect to Cleaning Validation, Computer System Validation and PQR. • To prepare impact assessment and risk assessment as or when required. • To provide support to other sections/departments with respect stability program and any data required for to PQR, Cleaning Validation, and Computer System Validation • To review AQR LL, HPR and other quality projects for assessment and actions related to above-mentioned sections. • To participate in self-inspection, Regional, Divisional and AQR Audits as an SME of above-mentioned sections. • To implement Audit CAPAs of above-mentioned sections in timely manner • Any other responsibility, assigned by Quality Control Manager or Head of Quality Assurance. • As an SME support will be provided to Stability Section when required. Education/Knowledge & Experience:
• M.Sc. Chemistry / Pharm-D • 8-10 years’ experience in the same capacity • Knowledge of requirement for QC/QA activities, Cleaning Validation, Computer System Validation problem resolution skills and other all activities taking place in QC/QA including knowledge of Annual product quality review. • Knowledge regarding Validation and Facility etc.