Executive I

3 days ago

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

Generic
- Implement Quality Assurance activities for Pharmaceutical at Ankleshwar adhering to standard operating procedures with optimum utilization of resources to ensure consistent good quality of products to meet with customers’ requirements, living Group’s Values and Code of Ethics.
- Specific additions (if needed)
- Not Applicable
- KEY ACCOUNTABILITIES
- Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- In process checks and sampling activity
- 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
- 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
- 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
- Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations
- Dimension (e.g. Budget, number of people managed)
- REQUIREMENTS
- Education / Experience
- Education:

- Graduate / Post Graduate in Pharmacy
- Experience:

- 1 - 3 years in Pharma industry with awareness of Quality management systems, manufacturing activities, process validation, Qualification, Regulatory requirements
- Technical skills &
- Competencies / Language- Knowledge of GMP and regulatory requirements-
- Good interpersonal skills and able to manage conflicts-
- Believes and lives in company values-
- Skilled in team work-
- Must be able to present complicated technical issues in an easy and understandable manner and obtain appropriate actions

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