We are seeking a detail-oriented and experienced QA Specialist to join our Quality Assurance team. The successful candidate will play a critical role in maintaining high-quality standards across analytical, production, and laboratory operations. In collaboration with the QA Manager, you will oversee compliance, lead internal audits, manage quality systems, and ensure strict adherence to cGMP guidelines.
Key Responsibilities:
- Master Records & Documentation: Review and approve Master Batch Records and operational procedures that directly impact product quality.
- Batch & Quality Reviews: Perform batch record reviews and author Annual Quality Reviews.
- Cross-Departmental Coordination: Work closely with Quality Control (QC) and Production departments to maintain seamless quality alignment.
- Audits & Compliance: Plan, schedule, and execute internal audits.
- Quality Systems Management: Manage deviations, Corrective and Preventive Actions (CAPA), and change control processes regarding analytical methods, production processes, and documentation.
- Risk Management & Complaints: Conduct risk assessment procedures, maintain related records, and handle customer complaints and returns.
- Training & Development: Plan and deliver annual training programs for QA/QC personnel (including audit training) and coordinate quality training for all company personnel.
Requirements
- Bachelor’s degree in Chemistry or a closely related scientific field
- Minimum 3 years in QA within a regulated pharmaceutical/API environment.
- Strong knowledge of cGMP standards, analytical testing procedures, risk assessment methodologies, and CAPA resolution.
