Biocon - Manager - Shopfloor Compliance - Pharma/Biotech

Manager ( Shopfloor Compliance ) Pharma / Biotech Background

- Inter Departmental co-ordination and compliance regarding manufacturing and obtain defect free products.

- To ensure the manufacturing processes and critical parameters of the processes of the sterile products are performed as per the respective approved procedure.

- To ensure the operations, activities and environmental conditions of the aseptic area to produce sterile products.

- Analysis and resolution of process problems.

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

- Identification and implementation ofcontinuous improvement measures and thereby making a effort to improve the product quality.

- To identify the gap as per the current regulatory expectations and support the department for implementation.

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

- To ensure the manufacturing processes and critical parameters of the processes of the sterile products are perfo1med as per the respective approved procedure

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

Behavioral I Management I Other Skills :

- Should have exposure of regulatory guidelines and audits.

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

Qualification :

- B. Phann I M. Phann I M.Sc.

Experience : 12 to 18years