Assistant Manager, Facilities and Engineering

The individual is required to coordinate planning, implementation, documentation and support manufacturing and laboratory operations and plant facilities. The role has to coordinate with all internal and external customers in a GxP environment by ensuring all activities and documentation is complaint with good documentation practices, quality compliance requirements, and applicable standard operating procedures.

• Manage the team to schedule work orders based on the priorities and ensure all documentation is compliant with Good documentation practices.
• Ability to check and respond to the Client/EMS alerts.
• Understand quality systems to include; Change Control, Deviations, CAPA s, Investigations and Audits.
• Plan and maintain spares and consumables for min-max and re-order levels.
• Schedule and coordinate periodic maintenance work / calibrations with external agencies as applicable.
• Adept in using CMMS and ERP.
• Must train people on the SOP belonging to respective departments by preparing question banks, initiating a self-study course or offline course or external training in Nichelon.
• Preparation of master equipment list.
• Preparation and finalization of preventive maintenance checklist and schedules.
• Preparation of master calibration list and calibration schedules.
• Ensure the execution of preventive maintenance and calibration schedules with internal or external sources.
• Review and verification of all calibration certification details and their archival.
• Issuance, execution and archival of all approved documents on timely basis as per respective SOPs.
• Develop procedures to induct new machines and maintenance procedures and coordinate with stake holders to ensure safe and compliant installation on time.
• Increase Safety Awareness and address any safety issues and concerns and ensures that equipment m.eets all relevant Health, Safety and Environment requirements
  
  Qualification:-
• Prior experience in a pharmaceutical, biopharmaceutical or other GMP regulated industry.
• Boiler Operator Certificate is a must.
• Minimum of 5 years experience in CGMP, QMS and Internal/FDA Audits.
• Experience with Microsoft Office products, such as Excel, Word, and Outlook.
• Strong planning, organization and prioritization skills with an ability to lead a team of mechanics.
• Ability to work independently with minimal direction and supervision.
• Intermediate ability to write reports, justifications, procedures, work orders and investigations.