Senior Manager - Production (OSD)

Job Role : Sr. Manager Production (OSD)

Job Location : Poanta Sahib

Job Function : Formulations (OSD)

Education : Graduate in Pharmacy (B. Pharm)

Experience : 15 to 18 yrs

Job Summary

1. Manufacturing and Packaging operations of Oral Solid Formulation.

2. Documentation operations of General Solid Oral Manufacturing and Packaging Department.

3. Ensure that Investigations, CAPA, Batch Records preparation completion schedule is prepared, tracked and, execution of schedule as per plan.

4. Review and production approval of documents like:

I. Commercial product, stability batches, exhibit batches, characterization Batches -

Master Batch manufacturing record and Master Batch Packaging record.

II. Risk assessment, process validation protocol, Incident and Investigation report,

CAPA Reports.

III. Protocols & reports.

V. Internal Quality Audit, Regulatory Quality Audit Compliance.

VI. Change control, Standard Operating Procedure, and other documents including

amendments.

5. Provide leadership and expertise to ensure achievement of production with respect to Quality

outputs and commercial demands.

6. To ensuring that there are appropriate manufacturing and technical processes and procedures in place for the production.

7. To ensure that products are produced and stored according to the appropriate documentation in order to obtain the required quality. The production records are evaluated and signed by a designated person.

8. In coordination with Quality head monitor the factor that may affect product Quality compliance of GMP, retention of records.

9. To approve the instructions relating to production operations, including the in-process controls, and to ensure their strict implementation.

10. To check the maintenance of the department, premises and equipment.

To ensure that the appropriate process validations and calibrations of control

1. equipment are performed and recorded and the reports made available.

2. To ensure that the required initial and continuing training of production personnel for SOP, cGMP, personal hygiene are carried out and adapted according to need.

3. Optimization of the resources like men, materials and machines in manufacturing and packing area.

4. Ensure efficient collaboration and co-ordination between relevant departments like Warehouse, Engineering, PPIC, Quality Control, Quality Assurance, procurement and management.

1. Supporting Compliance of internal quality/corporate quality/regulatory audit.
2. Planning & execution of various activities viz. Gap Analysis, enhancement, SOPs, protocols and reports etc.
3. To perform Risk Assessment with respect to investigations, internal / regulatory observation response, market complaints and for system improvements etc.

8. To co-ordinate with FDD, PDD (R & D) /MSTG for execution of trial/exhibit /Process validation batches and trouble shooting.

9. Procurement of New Suitable Equipments required for process as per cGMP requirements.

10. Identify and implement improvements to the production process, yield.

11. To ensure protection of the product from contamination. And monitor quality standards of products.

12. Shall delegate authority to deputed deputies with satisfactory level of qualification and experience.

13. Coach and develop direct and indirect reporters through on going, example based performance feedback, annual performance reviews and provision of training and development opportunities.

14. Assure all time readiness department for regulatory agency inspections/internal audits and appropriate implementation of corrective actions regarding observations made by the agencies and internal audit teams.

15. Shall participate in Internal Quality Audit.

16. Responsible for ensuring market complaints, failures deviations are investigated and corrective and preventive actions are implemented as per set timeline.

17. Performs all work in support of our Corporate Values of pride- Humility, Integrity, passion and with accountability and diligence. Perform all work in accordance with all established regulatory and compliance and EHS requirements.