The Assistant Quality Assurance Manager supports the Quality Assurance Manager in maintaining and continuously improving the company's pharmaceutical quality management system.
The role is responsible for ensuring that manufacturing, laboratory, warehousing, and related operations comply with GMP, GDP, regulatory requirements, company procedures, and applicable quality standards.
Key Responsibilities
Assist the Quality Assurance Manager in implementing and maintaining the Pharmaceutical Quality Management System (QMS).
Monitor compliance with Good Manufacturing Practices (GMP) and other applicable regulatory requirements.
Review and approve batch manufacturing and packaging documentation, SOPs, specifications, protocols, and other quality-related documents.
Support investigations of deviations, non-conformances, OOS/OOT results, complaints, and product quality issues.
Assist with root-cause analysis and the development, implementation, and monitoring of CAPA.
Participate in internal, supplier, and regulatory audits and assist with tracking audit observations to closure.
Support change control activities and assess the potential quality and regulatory impact of proposed changes.
Ensure proper implementation of document control and maintenance of accurate quality records.
Monitor environmental, hygiene, sanitation, and manufacturing practices to ensure compliance with established standards.
Support qualification and validation activities, including process, cleaning, equipment, and analytical method validation where applicable.
Review quality data and prepare reports, dashboards, and trend analyses to identify recurring quality issues.
Assist in ensuring that customer complaints and product recalls are investigated and managed appropriately.
Provide guidance and training to production, warehouse, laboratory, and other personnel on GMP and quality requirements.
Assist in the preparation for regulatory inspections and ensure timely implementation of inspection findings.
Promote a strong quality culture and continuous improvement across the organization.
Perform other QA duties assigned by the Quality Assurance Manager or Head of Quality.
Key Performance Indicators (KPIs)
GMP compliance and audit performance.
Timely closure of deviations and CAPAs.
Batch documentation review and release turnaround time.
Reduction in recurring quality issues.
Timely completion of change controls and investigations.
Training and compliance performance.
Customer complaint and product quality issue resolution.
Required Qualifications and Experience
Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, Biochemistry, or a related field.
Professional registration where applicable.
Typically 3 - 5 years of relevant pharmaceutical quality assurance experience, preferably in a manufacturing environment.
Practical knowledge of GMP, GDP, QMS, CAPA, deviation management, change control, risk management, and audit processes.
Experience with pharmaceutical documentation, batch review, investigations, and regulatory compliance.
Good knowledge of applicable national and international pharmaceutical regulations and guidelines.
Experience using quality management systems and standard office software.
Key Competencies:
Strong analytical and problem-solving skills.
Excellent attention to detail and documentation skills.
Good understanding of pharmaceutical manufacturing processes.
Strong communication and interpersonal skills.
Ability to work independently and effectively within cross-functional teams.
Good leadership, organization, and decision-making abilities.
High level of integrity, accountability, and commitment to product quality and patient safety.