Deputy Manager-Corporate Quality Assurance MSN Group

10.0 - 15.0 years

10 - 14 Lacs

sangareddy, patancheru, hyderabad

Work from Office

Role & responsibilities Harmonize QA SOPs and formats of MSN API divisions into corporate procedures in line with global regulatory guidelines (ICH, 21 CFR, EU, WHO). Prepare and distribute CQA SOPs and formats to respective manufacturing sites. Ensure timely initiation and closure of change controls, including impact assessments and approvals by relevant departments and Head CQA. Monitor the implementation of established procedures across API manufacturing sites. Provide QA support during regulatory inspections at sites, as needed. Manage document control activities, including issuance, archival, retrieval, and retention of GMP documents. Issue GMP-related registers and reconcile records across departments. Identify gaps in existing procedures vs regulatory guidelines through internal CQA audits. Facilitate harmonization of best practices and compliance findings across all API units. Review and trend quality metrics including change controls, OOS, OOT, lab incidents, etc. Prepare and present data for Management Review Meetings (MRMs). Conduct internal audits and support external audits when required. Deliver training on cGMP, SOPs, on-the-job activities, and other quality systems. Ensure effective implementation of digitalization systems across QA operations. Facilitate validation, risk assessment, change management, and scaling of new/modified digital systems. Perform periodic audit reviews of digital systems and ensure compliance with data integrity standards. Escalate resource requirements for digital system operations and represent digital QA systems during audits. Preferred candidate profile Sound knowledge of global regulatory requirements (ICH, WHO, EU GMP, 21 CFR Part 11, etc.) Strong documentation and quality systems management skills. Experience in handling digital QA systems and document management platforms. Proficient in data integrity, CAPA management, change control, and deviation handling. Excellent communication, collaboration, and problem-solving abilities. Ability to train and guide cross-functional teams.

Posted 4 days ago

Apply

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.