Specific Responsibilities:
- Drive the client and regulatory audits and address the audit finding related to BMP5 Facility.
- 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 equipment which are related to Facility Management and responsible for adherence to current SOP and safety requirements.
- 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.
- Training to the facility team to established procedures and ensure compliance by all personnel.
- 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.
- Review of Facility management and kill system related records and documents.
- Perform the GEMBA and safety walks for production area and other common area of BMP5 facility.
- 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 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.
- Leading of BMP5 facility related activities by adhering to Syngene s safety and GMP practices.
Education
Master s degree/ bachelor s degree in pharmacy, Master s degree in Pharmaceutical Sciences.
Industry Experience
Minimum 6-8 years of relevant practical experience in Facility management/ Pharma industry.
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.
