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Executive - Quality Assurance, Pharma at Zentiva — Ankleshwar, IND | Base Career | Base Career
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Executive - Quality Assurance, Pharma
Ankleshwar
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Search jobs like thisExecutive - Quality Assurance, Pharma Entry · 1+ years experience SAP Hana LIMS eDMS Track Wise
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SAP Hana LIMS eDMS
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Key Skills for This Role SAP Hana LIMS eDMS Track Wise
Full Job Posting 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 Improvement a. Line Clearance and shop floor compliance b. 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 site e. Assisting in Qualification and validation system, change control system, deviations f. Preparing & review the Annual Product Quality Review g. Review of Batch Manufacturing & Packing Records h. Coordination of cGMP Training activity. 2. Compliance Ensure adherence to company Quality Standards, Local FDA MHRA regulations, by i. Understanding the requirements
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ii. Performing the Gap analysis to find out the gaps in existing system
iii. Preparing a compliance plan for closure of gaps
iv. Execution of compliance plans
v. Review of completion for compliance activity
3. Validations & Qualifications:
a. Ensure validated status of all equipment’s, manufacturing processes, and cleaning processes
b. Review of protocols for qualification and validation of facility/ equipment / product / process
c. Review of validation reports after execution of validation of facility /equipment / product / process
4. Documentation Control:
a. Preparation and Review of SOPs
b. Controlled distribution and archival of documents & record
c. Control of master documents
5. Assuring quality of products by :
a. Ensuring SOP compliance
b. Review of Batch Manufacturing & Packing Records
c. Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
d. Ensuring the effectiveness review of the implemented CAPA
6. cGMP Training:
a. To prepare training modules and organize training in GMP
b. Execute the training program in coordination with all concerned departments
7. Other:
a. Review of maintenance and calibration program. Pharmaceutical Manufacturing 5400 employees
Private European pharmaceutical company developing, manufacturing, and supplying affordable generic, specialty, and over-the-counter medicines.
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