Company: Instrumentation & Control Solutions (ICS)

Experience: 7+ Years in Pharma QA

Location: Goa

Designation: Sr. Executive/Asst. Manager

Company Website- https://iapl.ics-india.co.in/

Job Type- Full Time

Contact No- 9109188512(Ankur Tiwari-ICS_HR)

Roles & Responsibility: -

A) KEY RESPONSIBILITIES:

• Preparation of all validation documents as per standards.
• Timely and efficiently completing the assigned task with team coordination.

B) KEY ACTIVITIES TO BE PERFORMED:

1. Prepare, review, and execute qualification documents for equipment, utilities, and facility systems.

2. Develop and execute qualification protocols such as:

3. URS (User Requirement Specification) , DQ (Design Qualification),IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification)

4. Support FAT and SAT activities wherever applicable.

5. Ensure traceability between URS, Risk Assessment, and Qualification documents.

6. Prepare and review all CSV documents related to software/application.(If applicable)

7. Develop and execute validation documents (Validation Plan, System requirement specification, Risk Assessment Installation Qualification, Operational Qualification and Performance Qualification etc.)

8. Author key validation deliverables like Validation Plan, Test Plans, Summary Reports, etc.

9. QMS handling, CAPA deviation and Change Control management, handle administration of site-specific applications in QC, Manufacturing and Engineering.

10. Review SOPs, protocols, reports, and qualification documents as per QA guidelines.

11. Ensure document compliance with regulatory and internal quality standards.

12. Support preparation and revision of site-specific SOPs.

13. Ensure the execution of all processes complies with various worldwide regulations

i.e. GAMP 5, 21CFR part 11, EU Annexure 11.

14. Assist in 21 CFR Part 11 Assessment.

15. Understand and adhere to the Quality manual, SOP on Project Management, Change Management, Document Management, and Quality Management.

16. Responsible to Prepare & Review Standard Operating Procedures/relevant

documents.

17. To articulate and explain information to customers and reporting managers.

18. Responsible for successful completion of assigned validation tasks and preparation of validation deliverables.

19. Prepare / revise site specific SOPs to ensure compliance.

20. Coordination with the team members, superiors, and subordinates within the group and across all relevant groups to complete action items as planned.

21. Responsible to review the validation documents properly as per the guidelines.

22. Responsible to maintain assigned projects completion MOM’s and Invoice.

23. Responsible to complete the assigned task given from site team lead/Client.

24. Attend training programs as per the company training calendar and needs.

25. Responsible to review the site documents /compliances.

26. Coordinate with cross-functional teams (QA, Engineering, Production, QC).

27. Accountable for providing additional contributions to organizational growth.