Title:  Sr. Specialist - QA (Sterile)

Position Summary :

1. In this role you will be responsible to adhere and ensure compliance cGMP principles and maintain them in effective manner.
2. Deviations investigation
3. Participate in the media fills.
4. Preparation of Process /Facility/Equipment Risk assessments
5. Should have Quality mindset in the process and procedural review.
6. Regulatory Audit exposure and Participate in Internal and External Audit programs.
7. Perform in-process quality check activities according to SOP in production / packaging departments (Sterile Injectable) in complying with cGMP principles and captures test results in batch records.
8. Check the required tests for all products during production / packaging process.
9. Inspect and check incoming materials by confirming specifications and return unacceptable materials.
10. Revise all documents for in process control and perform a quality review of logbooks.
11. Responsible to revise and document for inspection results and complete all required documents for in process control by completing reports and logs, summarizes re-work and waste, and inputs data into quality database on SAP system.
12. Preparation of Annual Product Quality Review reports.
13. Ensure the in-process check equipment’s are adequately calibrated and functions properly.
14. Perform and check the line before start (production/packaging) and give the clearance for the work.
15. Check all material required for manufacturing steps (production/packaging).
16. Maintain accurate records and perform tests on all activities conducted in the plant.
17. Plan and assign daily job duties to fulfil the plan.
18. Accomplish quality and organization goals by completing related results as needed.
19. Maintain safe and healthy work environment by following standards and procedures and complying with regulations.

Core Competency :

1. In terms of competency, you are highly result-oriented with keen sense of accountability & ownership.
2. High on compliance adherence, having strong diligence, initiative-taking and flexible.
3. Effective communication, interpersonal, and collaboration skills.
4. Should be having good learners mind to understand and grasp new learnings.
5. Motivated, organized, focused & overall compliance.
6. Must be able to manage tasks, plan workload effectively, priorities and easily adapt to changing situations.
7. Ability to understand new learnings and implant in workplace.

Qualifications, Key Experiences / Functional Knowledge Requirements:

1. Bachelor I master’s degree in pharmacy
2. Knowledge on EU Annex-1
3. Minimum 3 years in quality operation in Sterile manufacturing
4. Good Computer knowledge and knowledge of QMS system “Agile, Trackwise, Ampelogic”
5. Proficient in English.
6. Quality and Business decisions taker
7. Good Knowledge and command on cGMP
8. Risk Assessment knowledge