Lead Project & QMS in charge

Safety

To place safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures, and SOPs, in letter and spirit

Primary Responsibility,

• 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 always.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements always 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

• To ensure compliance to Safety at workplace and place Safety at number one priority with Engineering and Projects.
• Ensure chemical development manufacturing facility equipment’s, premises, utility systems are well maintained as per GMP and GEP requirements.
• Responsible for facility modifications and maintenance activities of chemical development manufacturing facility. 
• Involving with User and CFT team during equipment, campaign process and facility modification risk assessment and quality management system.
• Responsible for KAVACH program implementation as per the plan.
• Responsible for SQDEC program regular updates.
• Adhering to DI, Quality, Energy, Hygiene and EHSS policies.

• Execution of major modification and maintenance activities related to manufacturing facility, equipment preventive maintenance, breakdown maintenance planning, execution and validation, in coordination with user.
• Adhering to regulatory & statutory requirements related to functional areas.
• Ensure all the audit findings are closed within the stipulated time.
• Statutory responsibility that include getting certified elevators, pressure vessels, lifts stackers.
• Conducting periodic self-inspection.
• Train and develop team to perform regular maintenance activities
• Costing and budgeting of respective functional area.
• Ensure compliance of any audits related to QMS and EHSS management system.
• Assign objectives for the team members.
• Training on SOP’s for the team members.
• Implementation of cGMP, GEP, SOP as applicable.

• Review deviation reports, deviation requests and change controls.
• Review and approval of qualification and study protocol, approval of post execution documents.
• Approve purchase request pertaining to spares and other consumables.
• Approve specific equipment for use after maintenance activities.
• Evaluate the personnel who have undergone training.
• Authorize the invoice, bills and vouchers for the goods received.
• Approval of specific equipment for use.
• Review of documents related to QMS and EHSS management system.
• Review of invoice, bills and vouchers for the goods received.