REQUIREMENT: Exposure of Regulatory Audit minimum 04-05 times Independently (USFDA, TGA, EU, MHRA).
Candidate Profile
- 12-20 yrs. exp. in engineering department (Formulation Plant Only).
- Good Knowledge and exp. in automated equipment required for Electrical, Maintenance & Utility.
- Should have a minimum of 8+ years of experience as an Engineering Manager, with independent management of an Engineering department, and substantial exposure to regulatory environments.
- Ability to effectively manage an engineering team.
- Must have handled USFDA, MHRA, and TGA & EU Regulatory Audit.
Job Description
Responsible for maintenance and utility management, project oversight, cost-saving initiatives, manpower management, regulatory compliance, and on-time execution of projects and shutdown plans.
Day-to-Days-Responsibilities
- Monitoring and reviewing the operation and maintenance of equipments and facility catering to Process, HVAC and Utility equipment.
- Planning, Supervising and performing the planned preventive maintenance activity of Process, HVAC and Utility Equipment's as per SOP and approved schedule.
- Monitoring and Supervising the HVAC operations for temperature and relative humidity continuously and for automated control system.
- Provide quality service system such as, potable water, Steam, compressed air, Vacuum etc.
- Maintain and monitor the HVAC and Utility system.
- Ensuring and updating document entries in daily logbooks of Utility Equipment's, HVAC, Preventive maintenance Records, etc.
- Planning and Initiation of Capital Expenditure Request as per approved proposal related to facility, equipment's, safety compliance and energy conservation. Tracking of CER for the timely approval from concerned stakeholders.
- Involvement in the planning of new facilities and equipment or their replacement.
- Providing the engineering support like modification / upgradation / changes required for the new product. Adhering the timelines for the completion as per target.
- Ensuring proper housekeeping and upkeep of Engineering areas (Service or Utility areas, Calibration/Validation Room, Technical areas, Hoist Machine rooms, Plant terrace, etc.)
- Identifying and implementing of various measures for controlling and reducing the available OPEX expenses by spare management and vendor development.
- Identifying new technologies and vendor development for the system improvement and ease of operation and maintenance.
- Ensuring the optimized inventory in engineering stores. Ensuring the availability of Critical spares required to avoid major production delay.
- Estimating the cost for maintenance, major modification and project activities.
- Planning and Co-ordinating with contractors and vendors for the scheduling of maintenance activities. Ensuring close supervision while execution of critical task for maintaining the quality and safety standards.
- Co-ordinating with concerned department in charges for timely execution of engineering activities. Tracking to be done for all the activities as per plan.
- Ensuring on-line bill processing against the availed services for the timely payment to vendor.
- Ensuring the statutory compliance related to process and utility equipment's, HVAC and facility in coordination with EHS and other departments.
- Initiation of Purchase requisition for material and service procurement. Co-ordinating with purchase and vendor for clearing technical queries. Tracking of PR till the release of PO.
- Follow the cost approval flow before executing job.
- Ensure to attend the breakdown of machineries on time to have less impact on Quality and production and hand over.
- Inspection of material received at engineering stores and approving the same and maintains the required inventory level for all equipment spares and Consumables.
- Ensure timely executing Validation, Qualification and Calibrations protocols.
- Updating and reviewing status labelling of equipment's, instruments and colour coding of Utility lines etc.
- Adhere to general overview of calibration.
- Follow-up with external vendors.
- Operational Excellence through implementation of Lean initiative such as 5S, Kaizen at shop floor.
Gmp
- Review and update all engineering SOPs, Layouts and other related documents along with quality assurance.
- Following and execution of the appropriate HVAC and Utility validations, calibrations and qualification of all equipment are performed, recorded and reports are made available and suggesting changes for simplification of SOPs.
- Co-ordinating the temperature and relative humidity distribution study of store areas, manufacturing areas, cold storage etc.
- Co-ordinating the self-inspection and / or quality audit that regularly appraises the effectiveness and applicability of the Quality assurance system.
- Ensuring and maintaining the facility & equipment's for all audit readiness. Monitoring and tracking of all the QMS tasks like, CR action, CAPA actions, and deviations for timely closure.
- Following and adhering to the current Good Manufacturing Practice (cGMP) practices for making continual improvement in Quality system.
- Following and adhering departmental standard operating procedures (SOP) & protocols and implementing the suggestions / ideas for simplification and improvements.
- Giving training to the team.
Qms
- Operating software systems.
- Ensuring the timely reporting and acknowledgement of non-conformances. Ensuring the timely completion of investigation with root cause analysis and appropriate CAPA in place.
- Initiate the Change Request.
- Investigate and Initiate the deviation.
Ehs
- Following work authorization permit system & execute the work.
- Making sure that personnel health, hygiene and organisation practices are followed.
- Preparing and implementing the risk analysis of non-routine maintenance activities, system, equipment and process.
- Monitoring safely operation of machine as per SOP with maximum efficiency
- Adhere to general electrical safety.
- Reviewing and updating the compliance of safety observations. Critical observations should be addressed immediately.
- Monitoring plant hygiene and adherence to Health safety and environment policy of the organisation.
- Performing the risk analysis, hazops of non-routine maintenance activities, system, equipment and process.
- Investigation of safety incidences with root cause analysis and appropriate CAPA in place to avoid the re-occurrence. Learning and sharing to be ensured among the concerned team.
Training
- Identifying and conducting trainings to subordinates & Contractors for their development and improvement in skills and knowledge.
- Administrative:
- Identify areas of wastage.
- Co-ordinates with contractors and sub-contractors for scheduling of work.
- Supervision and Motivation of personnel
EnMS
- Follow the energy management guidelines & systems and conduct energy Internal Audit, Action plan and compliance.
- Develop a program of energy-saving projects & measure, verify the savings achieved.
- Identifying and implementation of Energy Saving Measures at unit level. Adhering to Energy Management System (EnMS) SOPs and related documents.
Others
- Performing any other assignment allocated.
- Planning and execution of plant shutdown activity.
