Title: Executive - Facility Management
Job Title: Executive
Job Location: Bangalore
Job Grade: 9
Reporting To: Deputy Manager
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
- Overall adherence to safe practices and procedures of oneself and the teams aligned
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
- Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory trainings related to data integrity,health, and safety measures are completed on time by all members of the team including self
- Compliance to Syngene’ s quality standards at all times
- Hold self and their teams accountable for the achievement of safety goals
- Govern and Review safety metrics from time to time
- Operation and Supervision of Sterilization Autoclave and Decontamination Autoclave
- Monitor disinfectant preparation and ensure appropriate documentation
- Preparing daily routine facility cleaning disinfectant solution and ensure appropriate documentation.
- Supervise cleaning & sanitization of the clean rooms, maintain and review the records.
- Facilitate and monitor daily availability of all the require material in clean rooms (Gowns, gloves, disinfectants etc.) as per the Standard Operating Procedures.
- Facilitate and monitor Waste management as per established procedures.
- Preparation of qualification documents URS, SLIA, Validation Plan, System Boundary, CLIA, DQ, RA, RTM, IQ, OQ and PQ and applicable deliverables based on qualification procedure.
- Lead and supervise operation of clean utilities related to Facility Management of BMP4
- Execution and documentation of qualification activities for Facility Management of BMP4.
- Ensure training and supervision of Facility Management of BMP4.
- Monitoring and execution of routine Fumigation activity.
- Coordination with cross functional team for all BMP4 Facility Management documents review and approval.
- Execution of qualification activities for BMP4 Facility Management equipment’s.
- Preparation and revision of SOPs related to facility and process equipment’s.
- Qualification, Requalification and Validation of Sterilization Autoclave, EMS and Clean Room Equipments.
- Preparation and revision of Forms and checklists and associated Facility Management documents in operations.
- Compliance to current Good manufacturing practices and keep facility ready all the times as per regulatory requirements.
- Maintenance of quality records.
- Adherence to Standard Operating Procedures, Operational control procedures
- Verification of operations equipment calibration.
- Adherence to pollution control and safety requirements.
- Meet training requirements
- Ensuring readiness of prerequisites for batch activities
- Ensuring readiness of facility for audit
- Execution of BMP4 manufacturing operations by adhering Syngene safety and GMP practices.
- Coordination with PPIC team and purchase team for Material requirement in BMP4 Facility Management.
Education and Experience
B.Sc with 6 to 9 years/M.Sc with 1-3 years of relevant experience
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 https://syngeneintl.com/ to know more about us and what we do.