Executive - Quality Assurance, Pharma

Zentiva Poland; India; On-site; INR 600,000 - 1,200,000; Full time

Job summary

A leading pharmaceutical company in India is seeking an Executive for Quality Assurance to ensure compliance with quality standards. The ideal candidate will have 3 to 5 years of experience in an OSD manufacturing unit and will be responsible for complaint investigations, SOP preparation, and cGMP training. The role requires a B. Pharm / M. Pharm degree and offers a full-time position.

Qualifications

• 3 to 5 years of experience in a regulatory-approved OSD manufacturing unit.
• Knowledge of GMP and Quality Standards.
• Experience in preparing SOPs and compliance documentation.

Responsibilities

• Ensure adherence to Quality Standards and Local FDA regulations.
• Assist in Complaint Investigation and validation systems.
• Prepare and review SOPs and compliance plans.

Skills

Quality Management

cGMP Compliance

Complaint Investigation

Documentation Control

Education

B. Pharm / M. Pharm

Job description

Executive - Quality Assurance, Pharma page is loaded## Executive - Quality Assurance, Pharmalocations: India / Ankleshwartime type: Plný úväzokposted on: Uverejnené dnesjob requisition id: R2468089**Job Description for Executive – Quality Assurance, Pharma****Educational Qualification*** **B. Pharm / M. Pharm from a reputed university****Experience*** **3 to 5 years of similar experience in a regulatory-approved OSD manufacturing large unit.****Quality Management/Continuous Improvement**Line Clearance and shop floor complianceAssisting 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 FDA MHRA regulations, byUnderstanding 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 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