Manager- Quality OSD Value Stream

Overall Responsibility

cGMP Compliance

• Monitor Good Documentation Practices, batch documents, logbooks, labels, gowning, cleanliness, and classified-area environmental conditions.
• Ensure equipment is used in a calibrated and qualified state and that SOPs and manufacturing or packaging instructions are followed.

Investigations and CAPA

• Review and approve deviations, complaints, recalls, and product quality investigations.
• Review and approve CAPA and change controls for related plants and products in Ample Logic.
• Ensure investigations are completed on time and corrective actions are properly implemented.

Inspections and Quality Improvement

• Perform regular site inspections and monitor self-inspections and GMP inspection CAPA compliance.
• Implement the Quality Improvement Plan and coordinate cross-functional teams to establish and spread Quality Culture.
• Approve Batch Manufacturing Records and Batch Packaging Records.

Product Lifecycle Management

• Lead QA oversight for technology transfer, process validation, commercial manufacturing, continued process verification, and product discontinuation.
• Review APQR or PQR trends, ongoing stability programs, lifecycle risk assessments, and continuous improvement initiatives.

Documentation and Training

• Review technical SOPs, risk assessments, GMP documents, qualification and validation protocols and reports, and facility or utility layouts.
• Lead batch document audits and retention sample checking.
• Develop and deliver training on batch release, documentation, compliance standards, quality, and cGMP systems.

Batch Release and Compliance

• Ensure batch release documentation and processes are audit-ready for internal and external audits.
• Make the final Usage Decision after reviewing complete batch documentation.
• Supervise final shipment checks and address batch-related compliance issues.
• Ensure in-process quality checks and test results are properly captured in batch records.

Qualification and Functional Knowledge

• Bachelor of Pharmacy.
• Minimum 10+ years of Quality Assurance oversight experience in oral solid dosage manufacturing operations.
• Batch release and product lifecycle management experience.
• Experience with quality management systems and knowledge of cGXP and risk assessment.
• Excellent oral and written communication skills in English.

Core Competencies

• Strong process compliance, accountability, ownership, discipline, organization, and time and task management.
• Excellent team-building, communication, training, coaching, incident investigation, root cause analysis, and CAPA implementation skills.
• Monitor, train, and guide teams on EMS and HSE requirements and drive environmental performance improvement and HSE culture.

Health, Safety and Environment

• Maintain a safe and healthy work environment by following standards and procedures and complying with applicable regulations.