We are seeking a detail-oriented and experienced Quality Assurance (QA) Executive to join our team. You will be responsible for ensuring compliance with quality standards and regulations in all aspects of our operations. The successful candidate will play a key role in maintaining the integrity of our processes and products through meticulous review, monitoring, and coordination.
Role and Responsibilities:
- Preparation, controlling, issuance & revision of BMR & BPR.
- Initiation, review, monitoring, tracking and closure of change control.
- Review of Batch Documents (i.e. BMR, BPR, Analytical reports).
- Assist in Handling Market Complaint, Internal Quality Audit, CAPA management
Preparation and authorization of Production information file.
- Maintain records of BMR received from location, review of the same and follow up with Production and Location in case of any deviation found. Maintain a scan copy of relevant BMR.
- Review of Analytical method validation and Process validation.
- Induction and orientation to new QA staff.
- Control & follow up starting material up-to FP release from location.
- Review and issue of Batch Coding.
- Interdepartmental coordination/ discussion/ meeting if needed and reporting to management.
- Ensuring the requirements are completed within scheduled time.
- Preparation, issuance, controlling & revision of SOPs.
- Preparation APQR Reports.
- Review and investigation of Deviation, OOS, OOT.
- Preparation of Stability report
- Vendor Qualification and Evaluation
Qualifications and Skills:
- Bachelor's degree in Pharmacy, Chemistry, Biology, or related field.
- Previous experience in a Quality Assurance role within the pharmaceutical or related industry.
- Strong understanding of Good Manufacturing Practices (GMP), Positive Laboratory Practices (GLP), and regulatory requirements.
- Observation and Analytical Skills.
- Good organized work and time management.