Zentiva is inviting applications for the role of Executive – Quality Assurance, Pharma at its Ankleshwar location in India. This opportunity is suitable for candidates with experience in Pharma Quality Assurance and documentation, along with strong knowledge of cGMP, GDP, quality systems, batch documentation, APQR, and regulatory expectations.
Job Details
| Company | Zentiva |
| Position | Executive – Quality Assurance, Pharma |
| Position Title | Executive I – Quality Assurance, Pharma |
| Department | Quality Assurance |
| Location | India / Ankleshwar; Ankleshwar |
| Experience | 1-5 Years |
| Employment Type | Full time |
Job Description
The Executive – Quality Assurance, Pharma role involves supporting quality management, shop floor compliance, documentation control, validations, qualifications, cGMP training, and compliance activities at the site. The role requires attention to detail, coordination with cross-functional teams, and a commitment to data integrity and quality standards.
Key Responsibilities
Quality Management and Continuous Improvement
- Line Clearance and shop floor compliance.
- Carry out in-process checks and calibration of IPQC instruments.
- Handle e tools i.e. SAP Hana, LIMS, eDMS, Track Wise system.
- Assist in Complaint Investigation system at site.
- Assist in Qualification and validation system, change control system, deviations.
- Prepare and review the Annual Product Quality Review.
- Review Batch Manufacturing and Packing Records.
- Coordinate cGMP Training activity.
Compliance
- Ensure adherence to company Quality Standards, Local FDA MHRA regulations.
- Understand the requirements.
- Perform Gap analysis to find out gaps in the existing system.
- Prepare a compliance plan for closure of gaps.
- Execute compliance plans.
- Review completion for compliance activity.
Validations and Qualifications
- Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes.
- Review protocols for qualification and validation of facility/ equipment / product / process.
- Review validation reports after execution of validation of facility /equipment / product / process.
Documentation Control
- Prepare and review SOPs.
- Carry out controlled distribution and archival of documents and records.
- Control master documents.
Product Quality Assurance
- Ensure SOP compliance.
- Review Batch Manufacturing and Packing Records.
- Ensure implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints.
- Ensure the effectiveness review of the implemented CAPA.
cGMP Training
- Prepare training modules and organize training in GMP.
- Execute the training program in coordination with all concerned departments.
Other Responsibilities
- Review maintenance and calibration program.
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 and 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.
How to Apply
Interested candidates can apply online through the official Zentiva Workday application link given below.