Senior Manager Production
Job Summary
Job Description
Followings will be the Coe Job responsibilities of the position holder:
- Compliance to laid standards of current Good Manufacturing Practices (cGMP).
- Carrying review and approval of qualification of production equipment.
- Ensure compliance with specifications and validated methods.
- Training and evaluation of the Management and Non-Management staff for the qualification to specific task or to operate specific equipment.
- Preparation and review SOPs for related equipments and procedures.
- Raising review of requisition for the requirement of consumables items and check on its inventories according to their approved budget.
- Implementation of Quality Management Systems as per cGMP and international standards.
- Implementation of Corrective and Preventive Actions (CAPA) for non-conformances and self-inspection findings.
- To exercise effective control over environmental conditions in manufacturing and other related activities which may adversely affect the product quality.
- To Coordinate and approve calibration/maintenance of all production equipments and instruments with engineering / QA / QC and outside agencies.
- To carry out routine documentation per regulatory requirements.
- Adhere to specified working hours.
- To ensure and maintain cleanliness of production areas and equipment as per SOPs.
- Coordinate with production PPIC QC CQA PLM QA and others for smooth production activities.
- Organize the job responsibilities to the technicians officers executives assistant managers as per plan and to manage absenteeism.
- Verification of dispensed input materials against process orders.
- Continuous monitoring of in-process controls in all production areas. Continuous monitoring and improving production output on daily basis.
- To fill maintain and approve BPR/BMR online and to ensure online SAP entries.
- To evaluate and sign production records before QA submission.
- To review production and related documentation.
- To Monitor and control of manpower utilization yield waste and Opex.
- To Ensure audit readiness and regulatory compliance.
- Handling of online systems and software and ensure review and approval in systems like SolTRAQs ISOtrain Darius Brainshark Harmony etc.
- Ensure the compliance of SAP activities related to updation of BOM creation of new item codes batch transactions etc.
- Ensure compliance with BBS and BBQ.
- To conduct self-inspection/internal audits as per site Internal Audit Program. To Investigate and provide CAPA for audit observations (internal and external). To conduct cGMP and GDP training in LVP facility.
In absence of the position holder the sub-ordinate / assistant Manager working in the section or the authorized designee (as applicable) shall be responsible for day to day working.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
Required Experience:
Senior Manager
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more