Executive - Quality Assurance, Pharma

Zentiva Poland; India; On-site; INR 600,000 - 800,000; Full time

Job summary

Zentiva Poland is seeking an Executive in Quality Assurance to be based in India. This role involves compliance with Quality Standards, preparation and review of documents, and training colleagues in GMP. Candidates should possess a bachelor’s or master’s degree in pharmacy and 1-5 years of relevant experience.

The ideal candidate will have strong knowledge of cGMP, batch documentation experience, and effective communication skills to ensure quality assurance protocols are adhered to throughout processes.

Qualifications

• 1–5 years of relevant experience in Pharma Quality Assurance / Documentation.
• Strong analytical, organizational, and coordination skills.
• Commitment to data integrity.

Responsibilities

• Ensure adherence to company Quality Standards and Local FDA MHRA regulations.
• Prepare and review SOPs, ensuring compliance.
• Execute training programs in coordination with departments.

Skills

Strong knowledge of cGMP

Hands-on experience with batch documentation

Good understanding of APQR preparation

Strong analytical skills

Effective communication

Attention to detail

Education

Bachelor’s or master’s degree in pharmacy

Tools

SAP Hana

LIMS

eDMS

Track Wise system

Job description

## Executive - Quality Assurance, PharmaUchádzať salocations: India / Ankleshwartime type: Plný úväzokposted on: Uverejnené dnesjob 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.