DPP1 fill finish

Designation: Senior Executive

Job Location: Bangalore

Reporting to: Associate manager

Job Grade: 9 (I/II) (executive 9I) (Senior executive 9II)

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.
• 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.
• 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.
• 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 4 - 5 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.

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