Lead Project & QMS in charge (Bangalore, KA, IN, 560099) en None

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.