FULL TIME

Job Description
Job Title: Assistant Manager
Location/Site: Baddi
Department/Division/ Unit: Production (LVP)/HMXL
Skill, Education, Experience Skilled in Injectable’s Operations, B. Pharma, +-10 Years
Experience +-10 Years
Industry Pharma (Injectable/Parenteral)

JOB DUTIES/ RESPONSIBILITIES/ ACCOUNTABILITIES:
1. Compliance to laid standards of the current good manufacturing practices.
2. Carrying and reviewing the Qualification of Production equipment.
3. Handling of manufacturing, filtration, filling and packing area.
4. Exposure to Large Volume Parenterals and Terminal sterilization.
5. Compliance to specifications and validated methods.
6. Evaluation of the Production Technicians for their qualification to specific task or to operate specific equipment.
7. Preparation and Review of Standard Operating Procedures, for related equipment’s and procedures.
8. Raising requisition for the requirements of consumables items and check on its inventories according to their approved budget.
+. Handling and raising Change Control, Exception and Planned Deviation of Quality Management System as per cGMP and international requirement at all levels of Manufacturing.
10. Preventive and corrective actions for observed non-conformance & self-inspection points.
11. To ensure effective control over the environmental conditions in Manufacturing and other related activities, which may adversely affect the product quality.
12. To co-ordinate for calibration / preventive maintenance for all production equipment’s and instruments with engineering / QA / QC & outside agencies.
13. To carry out routine documentation as per Regulatory Requirements.
14. To work within the specified working hours.
15. To ensure maintenance of production Area and equipment’s in the state of cleanliness as per the SOPs at all points of time.
16. Coordination with production Planning department for work order and Batch Record document with QA department.
17. Organizing the job responsibilities to the technicians as per plan & control on absenteeism.
18. Checking of dispensed input materials against process work orders
1+. Continuous monitoring of in-process controls in all production areas.
20. Continuous monitoring and improving the production output on daily basis.
21. To prepare, fill and maintain the BPR/ BMR online and to ensure online entries in SAP.
22. To review and evaluate the production records before they are sent to the QA department.
23. To maintain /fill the formats of Production and other related documents.
24. Ensure proper control of manpower utilization, yield, waste data.
25. To ensure all-time readiness for any audit.
26. Handling of online systems and software such as Track wise, DARIUS (if applicable)
27. Ensure compliance of SAP activities related to updation of BOM, creation of new item codes, SAP regularization etc.
28. Well versed with the track and trace system, automatic inspection, and secondary packing line handling.
2+. Have regulatory experience w.r.t audit facing and handling production activities.