Executive - Quality Assurance (Pharmaceuticals)

Zentiva Poland; India; On-site; INR 500,000 - 700,000; Full time

Job summary

Zentiva Poland is looking for an Executive in Quality Assurance in India. The ideal candidate will have a B.Pharm or M.Pharm degree and 1-5 years of experience in compliance and quality management.

Key responsibilities include ensuring adherence to quality standards, preparing documentation, and conducting training in Good Manufacturing Practices (GMP). Experience with various quality tools is essential.

Qualifications

• 1-5 years of experience in Quality Assurance.
• Experience in cGMP compliance and documentation.
• Knowledge of equipment validation and qualifications.

Responsibilities

• Carry out in-process checks and calibration of IPQC instruments.
• Ensure adherence to company Quality Standards and regulations.
• Preparation and review of SOPs and documentation control.

Skills

Quality Management

Continuous Improvement

SAP Hana

LIMS

eDMS

Track Wise system

Education

B.Pharm or M.Pharm

Job description

## Executive - Quality Assurance (Pharmaceuticals)Presenta candidaturalocations: India / Ankleshwartime type: Full timeposted on: Offerta pubblicata oggijob requisition id: R2469324**Job Title- Executive Quality Assurance (Pharmaceuticals)****Educational requirement****B.Pharm or M.Pharm with 1-5 years of experience.****Quality Management/Continuous Improvement**Line Clearance and shop floor complianceCarry 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 siteAssisting in Qualification and validation system, change control system, deviationsPreparing & review the Annual Product Quality ReviewReview of Batch Manufacturing & Packing RecordsCoordination of cGMP Training activity.**Compliance**Ensure adherence to company Quality Standards, Local EU, FDA, MHRA regulations, byUnderstanding the requirementsPerforming the Gap analysis to find out the gaps in existing systemPreparing a compliance plan for closure of gapsExecution of compliance plansReview of completion for compliance activity**Validations & Qualifications:**Ensure validated status of all equipment’s, manufacturing processes, and cleaning processesReview of protocols for qualification and validation of facility/ equipment / product / processReview of validation reports after execution of validation of facility /equipment / product / process**Documentation Control:**Preparation and Review of SOPsControlled distribution and archival of documents & recordControl of master documents**Assuring quality of products by :**Ensuring SOP complianceReview of Batch Manufacturing & Packing RecordsEnsuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaintsEnsuring the effectiveness review of the implemented CAPA**cGMP Training:**To prepare training modules and organize training in GMPExecute the training program in coordination with all concerned departments**Other:**Review of maintenance and calibration program.