Executive - Quality Assurance, Pharma

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.