Senior Executive

JOB ROLE DESCRIPTION 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 Responsibilities 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 Compliance with safety policy and procedures Facilitate and monitor the performance of regular facility walkthroughs and internal quality audits for biologics operations to ensure adherence to the implemented systems and compliance with regulatory requirements including data integrity assessment Responsibility for establishment and implementation of a robust cleaning sanitization sterilization process Monitoring of equipments which are related to Facility Management and responsible for review of logbooks and reports Lead and monitor management of garments and general consumables as per BMP5 facility requirements Review the SOP s protocols study reports procedures in BMP5 operations Lead and monitor timely tracking of Operational and Compliance Metrics for manufacturing Operations and management reporting Facilitate and monitor the implementation of the approved CAPA for the Biologics Operations in Facility Management section Facilitate and monitor waste management as per the established procedures and adherence to the Clean Room Behavior by all the personnel working in the clean rooms Leading the team in effective manner Leading the commissioning and qualification requalification of all equipment s which are related to facility management Support for timely reporting of deviations appropriate investigations to identify the root cause or most probable root cause and proposal implementation of appropriate CAPA to prevent reoccurrence Support for appropriate manufacturing investigations for OOS and results and customer complaint to identify the root cause or most probable root cause and proposal implementation of appropriate CAPA to prevent reoccurrence Support for risk management for biologics operations Facility Department which covers the following elements and ensured proposal and implementation of appropriate risk mitigation actions CAPA Quality and Compliance Risks Operational Risks Data Integrity Risks Facilitate and monitor timely preparation review and approval of GMP Documentation for BMP5 Facility Management related major equipment s Standard Operating Procedures EOP IOP and SOP Protocols and Reports Any other GMP relevant documentation Support for control of documents and records within the Manufacturing Operations Execution of BMP5 facility related activities by adhering to Syngene s safety and GMP practices Other competencies required for the role Follow the established Environment Occupational Health Safety and Sustainability EHSS practices for safe work environment and adhere to the highest standards of quality integrity compliance for every work activity Complete the assigned trainings in a timely manner and comply with the training procedure training calendar Attend all assigned mandatory trainings related to data integrity health and safety measures Compliance to Current Good Manufacturing Practices and Good Documentation Practices Adherence to Standard Operating procedures Operational control Procedures Participate in support the trainings on procedures protocols and On-the-Job activities Follow the discipline of reporting structure at times of escalation Report nonconformities deviations to the respective supervisor s and or line manager s Participate in support for on-time initiation closure of deviations investigations CAPA and change controls Safety and DI Responsibilities Adhere to organizational policies procedures on EHSS POSH Data Integrity and IT security Always wear the applicable PPEs and adhere to any other Environment Health and Safety EHS requirements in the workplace for individuals lab plant safety Understand all necessary safety protocols and always follow the same to ensure safety for all Proactively identify near-misses potential incidents and communicate to supervisor and or line manager or through the respective web portals 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