Senior Quality Assurance Manager Role

Job Description:

• Develop and Implement Quality Systems: Establish, maintain, improve quality audit systems, GMP quality systems, Behavioural GMP aspects.
• Vendor Qualification and Audits: Coordinate vendor qualification activities for Raw Materials, Packing Materials, Quality Control external testing Laboratories, outsourced activities, Internal Audits, compliance audits, Qualified Person audits, Regulatory Inspections.
• CAPA Management: Responsible for CAPA close out for all audits inspections.
• Document Control: Develop, maintain, improve GMP compliant document control system.
• Quality Management System: Establish robust Quality Management System (QMS) to manage implement change management, Deviation management, Incidents, complaint handling, CAPA management.
• Training and Development: Responsible for All GMP trainings Quality training programme, Lead manage ensure proper training to any relevant change management programs throughout company.
• Data Integrity: Provide quality guidance to product development projects programmes, Ensure Data Integrity Internal Audits Training, Review Reporting to management.
• Validation Activities: Ensure all validation activities (process/cleaning/method/equipment etc.) carried according approved protocols requirements.
• Regulatory Compliance: Ensure cGMP requirements quality standards recognized understood maintained across Company, Ensure all activities performed in accordance with GMP, company SOPs Health Safety policies.
• Self-Inspection Programme: Ensure there is self-inspection programme in place to meet requirements of EU GMP/PICS/TG/MHRA etc.
• Batch Manufacturing Record/Batch Packaging Record: Review approval issuing Batch Manufacturing Record / Batch Packaging Record.
• OOS/OOT: Responsible for OOS OOT.
• IPQA Activities: To monitor IPQA activities review report.
• cGMP Administrator: Responsible nominated by management as cGMP administrator.
• Preparation Review Finalization Submission of Documents: Responsible for Preparation Review Finalization time-to-time submission of documents if any to external customers Agencies per Regulatory Requirements.
• Validation Master Plan Schedule: Responsible for adherences Validation master plan adherences to Validation schedule.
• Control Sample Management Stability Management: Responsible for Control Sample Management (Final Retention Samples) along with QC Responsible for Stability Management along with QC team.
• Quality Review Meetings Management Review Meetings: Responsible for Quality Review Meetings Management Review Meetings.
• Documentation Cell Lifetime Documents Archival Programme: Responsible for Documentation cell Lifetime documents archival Programme.
• Artwork Approval Shade Card Maintenance: Responsible for Artwork Approval Shade card maintenance.
• Label Management Risk Management: Responsible for Label management Risk Management.
• Shredding Maintenance: Responsible for Shredding maintenance.
• Review Layouts Pest Control Management Fire Extinguisher Annual Documents: Responsible for Review of all Layouts along with Engineering Team, Responsible for Review of Pest Control management Fire Extinguisher Annual documents along with EHS HR Engineering Team.
• Water System Validation Documents: Responsible for Review Finalization of water system validation documents along with Engineering department.
• Transport Validation: Responsible for conducting Transport validation Review finalize protocol/Reports.
• National International Manufacturing Licensing Activities: Responsible for National International Manufacturing Licencing activities along with Regulatory Affairs team for Site Archival.
• Quality Agreements Vendor Agreements: Responsible for Quality Agreements Vendor Agreements adherence.
• All Dispatches Finished Products: Responsible for All dispatches of Finished Products as per country-specific approvals.

Required Skills and Qualifications:

• Bachelor degree in relevant field.
• Possession professional certification in Quality Assurance related field (e.g. CQPA CQE RAC).
• Minimum 5 years experience in Quality Assurance role preferably in pharmaceutical industry.
• Demonstrated expertise in GMP regulations quality systems documentation control.
• Excellent communication interpersonal skills.
• Ability to work effectively in team environment.
• Familiarity with regulatory requirements industry standards.
• Strong analytical problem-solving skills.

Work Environment:

• Work location: Ajmer IN.
• Industry: Pharmaceutical.
• Job type: Full-time.