Quality Assurance Job at Zentiva | Apply Now for the Officer Role
Zentiva is seeking an Executive – Quality Assurance for its large, regulatory-approved OSD manufacturing unit in Ankleshwar, India. This Quality Assurance Job requires 1 to 4 years of similar experience and a B. Pharm / M. Pharm qualification. The Executive will be responsible for ensuring shop floor cGMP compliance and system adherence, including executing Line Clearance, reviewing Batch Manufacturing & Packing Records (BMR/BPR), coordinating cGMP training, and participating in key quality systems like Qualification and Validation, Change Control, and Annual Product Quality Review (APQR), ensuring adherence to regulatory standards (FDA/MHRA).
- Job Title: Officer- Quality Assurance (Pharmaceuticals)
- Location: India / Ankleshwar
- Job Requisition ID: R2468772
About The Company
Zentiva is a producer of high-quality, affordable medicines and is a significant player in the European and global pharmaceutical market. As a large-scale pharmaceutical manufacturer, Zentiva operates regulatory-approved facilities, such as the Oral Solid Dosage (OSD) unit in Ankleshwar, India, where the Quality Assurance function adheres strictly to international standards, including Local FDA and MHRA regulations. Zentiva focuses on maintaining robust quality management systems, managing critical compliance processes (Validation, Deviations, CAPA), and ensuring excellence across all manufacturing and documentation practices. This makes the role in Quality Assurance pivotal.
Educational Qualification for the Quality Assurance Job
B. Pharm / M. Pharm from a reputed university is required for this Officer Job
Experience required for the Quality Assurance Job
1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit ensures you’re well-prepared for the Quality Assurance job at Zentiva.
Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- Assisting in the Complaint Investigation system at site
- Assisting in the Qualification and validation system, change control system, deviations
- Preparing & reviewing the Annual Product Quality Review
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity.
Compliance
- In this Officer Job ensure adherence to company Quality Standards, Local FDA MHRA regulations, by
- Understanding the requirements
- Performing the Gap analysis to find out the gaps in the existing system
- Preparing a compliance plan for the closure of gaps
- Execution of compliance plans
- Review of completion for compliance activity
Validations & Qualifications
- Ensure validated status of all equipment, manufacturing processes, and cleaning processes for effective performance in a Quality Assurance job.
- Review of protocols for qualification and validation of facility/equipment/product/process
- Review of validation reports after execution of validation of facility/equipment/product/process
Documentation Control
- Preparation and Review of SOPs
- Controlled distribution and archival of documents & records
- Control of master documents
Assuring Quality of Products
- Ensuring SOP compliance
- Review of Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
cGMP Training
- To prepare training modules and organize training in GMP
- Execute the training program in coordination with all concerned departments
