Senior Executive Fill Finish

Designation Junior manager 8 I Assistant manager 8 II Job Location Bangalore Reporting to Department Head Job Grade 8 I II The Company Syngene International Ltd BSE 539268 NSE SYNGENE ISIN INE398R01022 is an integrated research development and manufacturing solutions company serving the global pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical sectors Syngene s 4500 scientists offer both the skills and capacity to deliver great science robust data management and IP security and quality manufacturing at speed to improve time-to-market and lower the cost of innovation With a combination of 1 9 Mn sq ft of specialist discovery development and manufacturing facilities as well as dedicated research facilities for Amgen Baxter Bristol-Myers Squibb and Herbalife Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA Key Result Areas Role-specific 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 Education and Experience Education Master s degree bachelor s degree in pharmacy Master s degree in Pharmaceutical Sciences Industry Experience Minimum 7 - 8 years of relevant practical experience in sterile injectable for drug products etc Other competencies required for the role 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 Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities Pls visit us at to know more about us and what we do