Syngene is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.
Post : Senior Executive fill finish (DP)
Job Description
• Following GMP and GDP and data integrity
• Responsible for DP manufacturing facility manufacturing activities (operation and cleaning of autoclaves, compounding vessels, filtration vessels, pass-boxes, filter integrity machines, leak testing machine, glove integrity tester, LAFs, bag sealing machine, weighing balances, O’RABS, washing & tunnel with filling lines and packaging) for DP.
• Responsible for operation and cleaning of Automatic visual inspection machine and labelling machine for DP.
• Preparation, review and execution of Study protocol/SOPs/QRM/ Study report/QRM report in the drug product facility.
• Ensure QMS compliance in qualification and manufacturing related activities.
• Assist the validations/study and routine validations/study of equipment and facility.
• Identify and implement the manufacturing procedures with compliance to current GMP requirements and shop-floor area walkthrough on weekly basis.
• Coordinating with engineering and validation department for calibration, preventive maintenance and qualification.
• Assist the installation and commissioning activities like FAT, SAT etc. of DPM equipment’s.
• Performing/Executing/Assisting the IQ, OQ and PQ related to equipment’s in drug product facility.
• Preparation and review of SLIA, URS, CLIA, QRM, IQ and OQ documents and support for routine activities in DP manufacturing.
• Coordinating with cross functional departments to complete the QMS activities
• Preparation & review of all SOP’s/protocols related to equipment and drug product facility.
• Making the facility ready for various customer audits and regulatory audits.
• To maintain and review the audit trail, user privileges and alarms trending of critical equipment’s as and when required.
• Performing the FAT & SAT of drug product manufacturing equipment at vendor sites or at our facility.
• Preparation and execution of QMS documents in the department.
• Planning periodic training for operators and juniors related to SOP’s.
• Preparation and execution of training modules on QMS and safety SOP’s in the department.
• Supporting regulatory audits
Candidate Profile
• Master’s degree/ bachelor’s degree in pharmacy, Master’s degree in Pharmaceutical Sciences.
• Minimum 7 - 8 years of relevant practical experience in sterile injectable for drug products etc.
• Ensure QMS compliance in qualification and manufacturing related activities.
• Coordinating with cross functional departments to complete the QMS activities
• Completion of SAP related transactions (as applicable) related to functional work.
Additional Information
Experience : 7-8 years
Qualification : B.Pharm, M.Pharm
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : fill finish (DP)
End Date : 30th September 2025
