Officer- Quality Assurance

7 days ago

Ankleshwar, Gujarat, India Zentiva Group, a.s. Full time

Education:

  • Graduate/ Post Graduate in Pharmacy
  • Experience:
  • 03 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
  • Quality Management/Continuous Improvement
  • Release/rejection of Finished Products
  • Working as a key user for management of SAP Athena QM module.
  • Line Clearance and shop floor compliance
  • Implementation of Zentiva Quality Directives, Management and Control of Documents, such as SOPs, Master Documents, etc.
  • Implementation of Complaint Investigation system at site
  • Handling of Qualification and validation system, change control system, deviations
  • Preparing & review the Annual Product Quality Review
  • Review of Batch Reworking/Reprocessing/Reincorporation Documents
  • Review of Batch Manufacturing & Packing Records
  • Coordination of cGMP Training activity including training of the people
  • Handling of returned goods & recalls
  • Compliance
  • Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
  • Understanding the requirements
  • Performing the Gap analysis to find out the gaps in existing system
  • Preparing a compliance plan for closure of gaps
  • Execution of compliance plans
  • Review of completion for compliance activity
  • Review of the regulatory dossiers, as and when required
  • Prepare for and attend to external / regulatory Quality audits
  • Performing internal quality as a "Qualified Internal Auditor" during internal Quality Audit abiding the internal quality audit schedule
  • Validations & Qualifications:
  • Preparation, review and approval of Validation Master Plan
  • Ensure validated status of all equipments, manufacturing processes, and cleaning processes
  • Review of validation plans for facility / utilities / equipment / instrument / process / computer / cleaning
  • Review of protocols for qualification and validation of facility/ equipment / product / process
  • Review and certification of validation reports after execution of validation of facility /equipment / product / process
  • Documentation Control:
  • Preparation of quality system SOPs
  • Controlled distribution and archival of documents & record
  • Control of master documents
  • Issuance of batch records and log books
  • Assuring quality of products by:
  • Ensuring SOP compliance
  • Management of Events
  • Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
  • Investigation of Customer complaints / Recall
  • 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
  • Preparation of annual product quality review.
  • Management of external manufacturing activity.
- cGMP Training:

  • To develop training modules and organize training in GMP
  • Develop and execute the overall training program in coordination with all concerned departments
  • Other:
  • Preparation and review of site master file
  • Coordinating with various agencies for making of the technical agreements
  • Implementing the pest control program at Drug products
  • Review of maintenance and calibration program
  • Supplier audit qualification and approval
  • Identifying and correcting unsafe conditions or behaviours and promptly reporting other potentially hazardous situations

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