Senior Executive / Asst. Manager | OSD QMS

Role & responsibilities

1. To handle of all QMS related activities like Change control, Deviation (planned / unplanned), Market complaint etc.
2. Initiate and management of change controls (minor, major or critical) for process equipment, procedures and system for betterment and controls.
3. To prepare/revise the production records (BMR/BPR) for commercial as well as Exhibit / Engineering / Trial batches.
4. To prepare / revise SOPs / Qualification documents (protocol/report) / Validation documents (PV Protocol / report) / Hold time study documents (Protocol / reports).
5. To impart the SOP/BMR/BPR/Protocol (Qualification / Validation) training to subordinates and workers and maintain the training records.
6. To continuously review and identify the training needs of the workers working in the department and conduct the training program.
7. Responsible for Periodic Revision of SOP.
8. To impart the training to newly joined employee and prepare the training modules.
9. To support the validation team during execution of validation of the product manufacturing process and cleaning process.
10. To support or face the customer and regulator audits.
11. Implementations of cGMP systems and to ensure their compliance.
12. Co-ordination with all other departments & internal department for quality management and effective inter-departmental communication.
13. Production planning and co-ordination with allied department to run the department smoothly.
14. To maintain the cleanliness in production area during the production activity.
15. To check the maintenance of department, premises and equipments.
16. To Maintain the BMR and Log Book in production Area.
17. Maintain Quality and Quantity of product during Production.
18. Responsible for execution of Trail batches, Scale up batches, Exhibit batches etc. in DP-Formulation department.

Preferred candidate profile

• Candidate should have relevant experience in the pharmaceutical Industry, preferably in Oral Solid Formulations and have regulatory exposure to USFDA/ MHRA/EU/TGA etc.
• Should be assertive, proactive, and self-driven.
• Interested candidate can also share their CV at anil.patel@apotheconpharma.com

Perks and benefits

Best in Industry, EPRS