Executive - Quality Assurance, Pharma

Zentiva Poland; Ankleshwar; On-site; INR 480,000 - 600,000; Full time

Job summary

Zentiva Poland in Ankleshwar, India, seeks an Executive I - Quality Assurance to support pharma QA, documentation, and compliance. You will engage in line clearance, in-process checks, and oversee document systems like SAP Hana, LIMS, eDMS and TrackWise.

The role covers deviations, CAPA, and annual reviews, ensuring product quality and regulatory alignment. You will collaborate across functions, ensure SOP adherence, and assist in training and validation activities.

Qualifications

• Bachelor’s or Master’s degree in pharmacy, pharmaceutical sciences or life sciences.
• 1–5 years of relevant experience in pharma quality assurance and documentation.
• Strong knowledge of cGMP, GDP and quality systems.
• Hands-on experience with batch documentation and document control systems.
• Good understanding of APQR preparation and regulatory expectations.
• Attention to detail and commitment to data integrity.

Responsibilities

• Quality management and continuous improvement including line clearance.
• Carry out in-process checks and calibration of IPQC instruments.
• Handle SAP Hana, LIMS, eDMS and TrackWise systems.
• Assist in complaint investigations and CAPA workflow.
• Support qualification, validation, change control and deviations.
• Prepare and review Annual Product Quality Review.
• Review batch manufacturing and packing records.
• Coordinate cGMP training activities and compliant documentation.

Skills

cGMP knowledge

GDP awareness

Quality Systems

Batch documentation

Document control

APQR preparation

Analytical skills

Coordination

Cross-functional communication

Education

Bachelor’s or Master’s degree in Pharmacy/Pharmaceutical Sciences/Life Sciences

Tools

SAP Hana

LIMS

eDMS

Track Wise system

Job description

## Executive - Quality Assurance, PharmaApplylocations: India / Ankleshwartime type: Full timeposted on: Posted 5 Days Agojob requisition id: R2469337Position Title: Executive I - Quality Assurance, Pharma**Qualifications & Experience**Educational Qualification* Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline.**Experience*** 1–5 years of relevant experience in Pharma Quality Assurance / Documentation**Skills & Competencies*** Strong knowledge of cGMP, GDP, and Quality Systems* Hands-on experience with batch documentation and document control systems* Good understanding of APQR preparation and regulatory expectations* Strong analytical, organizational, and coordination skills* Effective communication and cross-functional collaboration abilities* Attention to detail and commitment to data integrity**Key Responsibilities**1. Quality Management/Continuous Improvementa. Line Clearance and shop floor complianceb. Carry out in-process checks and calibration of IPQC instruments.c. Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system.d. Assisting in Complaint Investigation system at sitee. Assisting in Qualification and validation system, change control system, deviationsf. Preparing & review the Annual Product Quality Reviewg. Review of Batch Manufacturing & Packing Recordsh. Coordination of cGMP Training activity.2. ComplianceEnsure adherence to company Quality Standards, Local FDA MHRA regulations, byi. Understanding the requirementsii. Performing the Gap analysis to find out the gaps in existing systemiii. Preparing a compliance plan for closure of gapsiv. Execution of compliance plansv. Review of completion for compliance activity3. Validations & Qualifications:a. Ensure validated status of all equipment’s, manufacturing processes, and cleaning processesb. Review of protocols for qualification and validation of facility/ equipment / product / processc. Review of validation reports after execution of validation of facility /equipment / product / process4. Documentation Control:a. Preparation and Review of SOPsb. Controlled distribution and archival of documents & recordc. Control of master documents5. Assuring quality of products by :a. Ensuring SOP complianceb. Review of Batch Manufacturing & Packing Recordsc. Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaintsd. Ensuring the effectiveness review of the implemented CAPA6. cGMP Training:a. To prepare training modules and organize training in GMPb. Execute the training program in coordination with all concerned departments7. Other:a. Review of maintenance and calibration program.