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Job Description
Provide support to Production Manager and work with the OSD finishing team to ensure planning, organizing, executing, training, and monitoring of all activities with compliance of EQDs’/ AQs’ Policies / Procedures, Local Regulatory, cGMP requirements, EHS policies and security standing orders / code of business conduct. Also support in QMS activities like change management, CAPA & Risk management activities related activities in finishing areas.
Major Responsibilities:
- To perform related Finishing operations as per S.O.P with proper documentation.
- Accountable to meet scheduled operation due dates, daily run rates, Continuous improvement plans, etc. in a timely manner.
- Timely compilation of batch records & maintain equipment logs.
- Maintain Housekeeping logbooks.
- Manage & supervise work force of area.
- To expose prioritize and stimulate the reduction or elimination of non-value-added activities and to reduce scrap, rework, and shrinkage, and to increase yields.
- To assist by providing information needed for measurement of KPI’s of supply side.
- To assist in root cause analysis against KPI’s results for continuous improvement of process.
- Ensuring that products are manufactured under controlled environment, meeting all EQDs’/ AQs’ EHS and Housekeeping Standards. Assure compliance with local and Abbott rules.
- To comply with security standing orders / code of Business conduct.
- Daily standardization of Balances & check weigher.
- To conduct the Validation activities timely.
- To comply with CAPA task implementation.
- To assess the risk of areas & processes.
- To be a part of change management activities.
- To evaluate the RCA of Market complaints & deviations.
- Responsible for trail batches finishing and submission of stability samples.
- To Ensure SOP in place and in use.
- Maintain positive employee relations atmosphere.
- To execute actions against GEMBA.
- To ensure timely closure of QMS related action of OSD Finishing Zoning Area.
- Any other work assigned by Production Manager.
Education/Knowledge & Experience:
- Science Graduate/Master; preferably Pharm D
- Must have sound knowledge & technical expertise about finishing operation of solid/Liquid/injectable dosage pharmaceutical products.
- 4 - 5 years’ experience in relevant field.
- Teamwork and problem-solving skills