Position Title: Executive I - Quality Assurance, Pharma
Qualifications & Experience
Educational Qualification
- Bachelor's or master's degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.
Experience
- 1–5 years of relevant experience in Pharma Quality Assurance / Documentation
Skills & Competencies
- Strong knowledge of cGMP, GDP, and Quality Systems
- Hands-on experience with batch documentation and document control systems
- Good understanding of APQR preparation and regulatory expectations
- Strong analytical, organizational, and coordination skills
- Effective communication and cross-functional collaboration abilities
- Attention to detail and commitment to data integrity
Key Responsibilities
- Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- Carry out in-process checks and calibration of IPQC instruments.
- Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system.
- Assisting in Complaint Investigation system at site
- Assisting in Qualification and validation system, change control system, deviations
- Preparing & review the Annual Product Quality Review
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity.
- Compliance
Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
- Understanding the requirements
ii. Performing the Gap analysis to find out the gaps in existing system
iii. Preparing a compliance plan for closure of gaps
iv. Execution of compliance plans
- Review of completion for compliance activity
- Validations & Qualifications:
- Ensure validated status of all equipment's, manufacturing processes, and cleaning processes
- Review of protocols for qualification and validation of facility/ equipment / product / process
- Review of validation reports after execution of validation of facility /equipment / product / process
- Documentation Control:
- Preparation and Review of SOPs
- Controlled distribution and archival of documents & record
- Control of master documents
- Assuring quality of products by :
- Ensuring SOP compliance
- Review of Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
- cGMP Training:
- To prepare training modules and organize training in GMP
- Execute the training program in coordination with all concerned departments
- Other:
- Review of maintenance and calibration program.
