Executive - Quality Assurance, Pharma

Zentiva Poland; India; On-site; INR 600,000 - 900,000; Full time

Job summary

Zentiva Poland in India is seeking an Executive I - Quality Assurance to lead QA activities, ensure cGMP compliance, manage documentation, and support validation and change controls.

The role involves line clearance, IPQC support, SAP Hana/LIMS/eDMS usage, CAPA closure, APQR preparation, and cross-functional collaboration with manufacturing, QA, and regulatory teams.

Qualifications

• 1–5 years of pharma QA/documentation experience.

Responsibilities

• Quality Management/Continuous Improvement including line clearance and shop floor compliance.
• In-process checks and IPQC instrument calibration.
• Support in complaint investigations and CAPAs.
• Assist in qualification, validation, change control, and deviations.
• Prepare/review Annual Product Quality Review.
• Review Batch Manufacturing & Packing Records and training activities.

Skills

cGMP & Quality Systems

Batch documentation

Document control

APQR preparation

Analytical skills

Organizational skills

Coordination skills

Communication

Cross-functional collaboration

Attention to detail

Data integrity

Education

Bachelor's or Master's degree in Pharmacy/Pharma Sciences/Life Sciences

Tools

SAP Hana

LIMS

eDMS

TrackWise

Job description

Position 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.