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
Solid knowledge of cGMP, GDP, and Quality Systems
Hands-on experience with batch documentation and document control systems
Valuable understanding of APQR preparation and regulatory expectations
Solid 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.