Technical/Functional Skills:

- Inter Departmental coordination and compliance regarding manufacturing plans and introduction of new molecules in order to achieve the product targets and obtain defect free products.

- Monitoring of manufacturing processes and critical parameters of the processes of the sterile products

- Monitoring of operations, activities and environmental conditions of the sterile area to produce steril products.

- Analysis and resolution of process problems.

- Carrying out the self - inspection of the department in coordination with QA Department an preparation of the compliance report.

- Identification and implementation of cost improvement/avoidance measures and thereby making a effort to bring down the cost of production.

- Technical up gradation of the section by modification of processes and systems from time to time. Capacities planning according to the increment in the production targets.

- Implementation an installation of current technologies and machines during capacity enhancement.

- Improving the department according to current Good Manufacturing Practices and the- implementation.

- Effective training and development of working staff at regular intervals to appraise them of the !ates changes in regulatory requirements, introduction of new technical concepts and to refresh the- knowledge about technical or safety aspects of their job.

- Carrying of planned validation of various manufacturing processes, equipment and machines and are of the department in coordination with validation team to ensure that the process, equipment an machine produce correct, flawless, consistent and reproducible products of high quality.

- Preparation and review of validation protocols and reports. Facing audits as well as audit compliance.

- Handling of Deviations, Change control, SOP, OOS, OOT and all other cGMP records. Review of Standard Operating Procedures (SOP) for all the activities of the department pertaining to area, men and machine in coordination with Quality Assurance Department.

- Carrying of planned validation of various manufacturing processes, equipment and machines and area of the department in coordination with validation team to ensure that the process, equipment anc machine produce correct, flawless, consistent and reproducible products of high quality. Preparation and review of validation protocols and reports.

- Ensuring of manufacturing of various sterile products as per the master formula record.

- Investigation in case of failures and handling of market complaints.

Qualification : B.Pharm/M.Pharm

Prior Work Experience 14 to 20 Years

- Planning and Scheduling of Production activities for optimum utilization of resources in the Production Department.

- Ensuring the availability of Raw Materials, Primary Packing Materials and other items that are essentials for Manufacturing Plan.

- Facing audits as well as audit compliance.

- Ensuring that the quality of products, processes and systems are in compliance with corporate quali policy and regulatory requirements.

- Achievement of production targets on time.

- Preparation of monthly and annual reports, like production achievement report, yields report, work- in-process report, etc.

Any Additional Notes/ Information:

- Safety Management by taking all safety measurements and bringing awareness of the safety aspects in the working staff.

- Adherence to safety health and environmental measures.

- Core Skills in Management and supervision.

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