The Assistant Manager – QA (QMS) is responsible for effective implementation, monitoring, and continuous improvement of Quality Management Systems including Change Control, Deviations, Investigations, OOS, CAPA, and Training systems. The role ensures compliance with regulatory requirements, data integrity, and timely escalation of critical quality events to management. The position also supports digitalization initiatives and contributes to management review through quality data trending and analysis.
Key Responsibilities
Quality Management System Oversight
- Review and manage Change Controls, Temporary Change Controls, Deviations, Investigations, OOS, and CAPA, ensuring timely closure of action plans.
- Perform day-to-day operations of the Quality Management System (QMS) in compliance with internal procedures and regulatory expectations.
- Ensure appropriate systems are in place for tracking, trending, and analysis of quality data, and provide meaningful input to Management Review Meetings.
- Escalate critical quality events to management in accordance with established procedures.
Investigations & CAPA
- Review and approve investigations related to deviations, non-conformances, and out-of-specification (OOS) results for drug product and/or drug substance.
- Actively participate in root cause analysis, ensuring scientifically sound investigations and effective corrective and preventive actions (CAPA) implementation.
- Monitor effectiveness checks and ensure sustainability of CAPA.
Regulatory & Compliance
- Maintain a thorough understanding of regulatory requirements related to drug product manufacturing, aseptic processes, and microbiology.
- Ensure QMS activities comply with applicable cGMP, regulatory guidelines, and data integrity requirements.
- Support regulatory inspections and audits by providing QMS documentation and responses as required.
Documentation & Data Integrity
- Ensure data integrity across quality system documentation and electronic systems.
- Prepare, review, and approve SOPs, policies, and procedures related to QA and QMS functions.
- Ensure document lifecycle management is followed, including periodic review and training effectiveness.
Digitalization & Continuous Improvement
- Provide support for QMS digitalization projects, including implementation, validation, and user adoption.
- Identify opportunities for process improvement and operational excellence within QMS activities.
Organizational & Leadership Skills
- Demonstrate strong organizational and time-management skills, effectively handling multiple priorities in a dynamic environment.
- Collaborate with cross-functional teams to promote a strong quality culture across the organization.
Key Competencies & Skills
- Strong knowledge of QMS processes (Change Control, Deviation, OOS, CAPA, Investigations, Training).
- Hands-on experience with regulatory audits and inspections.
- Expertise in root cause analysis tools and CAPA effectiveness.
- Sound understanding of data integrity principles (ALCOA+).
- Excellent communication, documentation, and stakeholder management skills.
- Experience with electronic QMS (eQMS) and digital quality systems preferred.
Qualification
M.Sc. / M.Pharm (Pharmaceutical Sciences or related discipline)
Experience
9–12 years of relevant experience in Quality Assurance with strong exposure to Quality Management Systems in pharmaceutical manufacturing.
