Officer - Quality Assurance (Pharmaceuticals)

2 days ago

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

KEY ACCOUNTABILITIES

Quality Management/Continuous Improvement
- Investigation of Deviations
- Implementation of Zentiva corporate policies, Management and Control of Documents, such as SOPs, Master Documents, etc.
- Review the Annual Product Quality Review
- Batch Reworking/Reprocessing/Reincorporation (Coordination from QA point of view)
- Review of Master Batch Manufacturing & Packing Records
- Coordination of cGMP training activity including training of the people
- Handling of change control system
- Document control
- Assisting in complaint investigations at site.
- Release/ rejection of semi-finished and finished products.
- Handling of self inspections
- Compliance
- Ensure adherence to company Quality Standards, Local FDA and other regulatory authorities
- 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
- Validations & Qualifications:

- Preparation & review of Validation Master Plan
- Ensure validated status of all equipment 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
- Management of archival room
- Issuance of batch records, ATR, logbooks and controlled formats.
- Assuring quality of products by:

- Ensuring SOP compliance
- Controlling the changes made to facility / equipment / product / process and master documents by following change control procedure
- Review of Executed 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
- Review of batch records & analytical testing records
- cGMP Training:

- To develop training modules and organize training in GMP
- Develop and execute the overall training program in coordination with all concerned departments
- QA in QC:

- Review of Specifications, protocols, reports and other GMP related QC documents
- Review of analytical incidents
- Review of OOS investigations and reports
- Review of Audit trial for Quality control instruments.
- Act as system administrator for Quality control instruments in NIR and Viscometer.
- Other:

- Implementing the pest control program at Pharmaceutical facility
- Review of maintenance and calibration program
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
- Dimension (e.g. Budget, number of people managed)
- Not Applicable

**REQUIREMENTS**:
Education / Experience
- Education:

- Graduate / Post Graduate in Pharmacy
- Experience:

- 02-04 years in Pharma industry with awareness of Quality management systems, method validation, Qualification, Regulatory requirements
- Behavioral Competencies
- (LEAD and others)- Accountability, Authenticity, Collaboration, Courage and Trust

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