Sr. Exe./ Asst.Mgr Production- For Pharma Formulation Plant, OSD Pune.

Role & responsibilities

Relevant Experience : Should have experience of Production for Formulation Plant of Oral Solids (Tablets, granules, powder) & Allied in PHARMACEUTICAL COMPANY / FACTORY.

FDA Approval in Tablet Section Pharma Formulation plant would be preferred.

1. Batch Manufacturing

Manufacture production batches as per Batch Manufacturing Record (BMR) and Batch Production Record (BPR).

2. BMR/BPR Documentation

Complete the online BMR and BPR as per the respective activities.

3. Coordination with QA

Coordinate with the Quality Assurance (QA) department for the issuance of monthly formats.

4. Manufacturing Parameters Review

Review parameters during manufacturing stages such as compression, filling, and packing for oral dosage products.

5. SOPs and Documentation

Prepare, update, and maintain Standard Operating Procedures (SOPs), BMR, and BPR documents.

6. Document Maintenance

Ensure proper maintenance of documents, including BMR, BPR, cleaning records, calibration logs, environmental records, and equipment usage logbooks.

7. Manpower Allocation

Allocate and manage manpower for the effective utilization of resources.

8. Production and Packing Oversight

Oversee and manage the overall manufacturing and packing activities in the oral department.

9. Compliance with cGMP & GDP

Monitor and implement Current Good Manufacturing Practices (cGMP) and Good Distribution Practices (GDP) within the department.

10. Quality Management System:

Handle the Quality Management System (QMS), including initiating, investigating, and completing change control, deviations, and incidents.

11. Equipment & Area Qualification:

Monitor and review equipment and area qualification activities and ensure timely reporting.

12. Validation Activities

Coordinate with QA and QC departments for product process validation and cleaning validation activities.

13. Production Target Achievement

Ensure daily and monthly production output targets are achieved.

14. Cross-Department Coordination

Facilitate coordination between Quality Assurance, Quality Control, Warehouse, and Engineering departments.

15. Material Availability Check

Ensure availability of required raw materials (RM) and packaging materials (PM) as per the production plan and schedule.

16. Training & Development

Conduct training programs on SOPs, GMP, technical procedures, and identify training needs for department personnel.

17. BMR/BPR Handover to QA

Ensure completed BMR and BPR are handed over to the QA department before dispatch activities.

Required Candidate profile:

1. 07-10 years of experience in Formulation Pharmaceutical Plant.

2. Relevant Experience in Pharma formulation plant.

3. Computer proficiency in MS Office, Excel, e-mail and internet functions, ERP