Executive – Quality Assurance, Pharma

Job title: Executive – Quality Assurance, Pharma

Company: Zentiva


Job description: Job Description for Executive – Quality Assurance, PharmaEducational Qualification

• B. Pharm / M. Pharm from a reputed university

Experience

• 1 to 4 years of similar experience in a regulatory-approved OSD manufacturing large unit.

Quality Management/Continuous ImprovementLine Clearance and shop floor complianceAssisting in Complaint Investigation system at siteAssisting in Qualification and validation system, change control system, deviationsPreparing & review the Annual Product Quality ReviewReview of Batch Manufacturing & Packing RecordsCoordination of cGMP Training activity.ComplianceEnsure adherence to company Quality Standards, Local FDA MHRA regulations, byUnderstanding the requirements Performing the Gap analysis to find out the gaps in existing system Preparing a compliance plan for closure of gaps Execution of compliance plans Review of completion for compliance activity Validations & Qualifications:Ensure validated status of all equipment’s, manufacturing processes, and cleaning processesReview of protocols for qualification and validation of facility/ equipment / product / processReview of validation reports after execution of validation of facility /equipment / product / processDocumentation Control:Preparation and Review of SOPsControlled distribution and archival of documents & recordControl of master documentsAssuring quality of products by :Ensuring SOP complianceReview of Batch Manufacturing & Packing RecordsEnsuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaintsEnsuring the effectiveness review of the implemented CAPAcGMP Training:To prepare training modules and organize training in GMPExecute the training program in coordination with all concerned departmentsOther:Review of maintenance and calibration program

Expected salary:

Location: Česko

Job date: Fri, 16 May 2025 07:38:40 GMT

To help us track our recruitment effort, please indicate in your email/cover letter where (jobsnear.pro) you saw this job posting.Thanks&Good Luck