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Sr. Executive QA

*This job is PAUSED right now, but may get open in the future. You may present your information by applying.*

Job Objective:

To establish and monitor ”Quality” for all aspect of good manufacturing practices(GMP)and other quality system pertaining and maintain its records/documents such as standard operating process(SOP),protocol of tests, results and reports.

Key Responsibility:

1.      To follow Quality Policy and IMS policy.

2.      To assists QA Manager/Asst manager to preparation of GMP documents.

3.      To maintain & control GMP documentation in QA.

4.      To Report QA Manager/Asst manager of day to day activities of department.

5.      To Monitor & Ensure GMP Implementation in plant.

6.      To prepare annual product Quality review & their trends as per review period.

7.      To Prepare SOPs, Quality Manual, VMP, SMF and Qualification protocol as per guideline.

8.      Issuance & retrieval of BMR as per applicability and production plan.

9.      To obsolete the old copy of BMR, SOP, s and other relevant documents at the time of change in version.

10.  To Ensure Environment Monitoring in plant.

11.  To draw the process validation samples as per process validation protocol along with QC persons.

12.  To give line clearance before initial activities in dispensing & Manufacturing.

13.  To monitor master lists of documents & masters in QA.

14.  To review GMP Documents as per applicability.

15.  To ensure that all master list of documents and masters are kept in

Quality Assurance documentations.

16.  Handling of change control, deviation and maintain their Log.

17.  Handling OOS/ OOT, Incident and CAPA, Maintain their Log.

18.  To perform Internal Audits.

19.  To follow-up and execution /documentation of MRM.

20.  To perform process validation activity.

21.   Review of BMR and ATDS.

22.  Issuance of Documents to concern departments as per applicability.

23.  To Implement and perform the procedures as per the Integrated Management system (IMS) which conforms to the requirement of ISO 9001:2015 (QMS), ISO 14001:2015 (EMS) and ISO 45001:2018 (OHSAS).

24.  Be aware of IMS policy and its intention, and his/her role in fulfilling the requirements of the IMS policy, and the consequences of not fulfilling the requirements

25. Comply to the PPE requirements and emergency preparedness requirements of the work being performed.

Skills and Competencies required – (Display the following written skills and Behavioral competencies which are required for this position)

1)     Confident, tact and a persuasive in nature.

2)     Team working

3)     Planning and organizing

4)     Promoting core values of the organization

5)     Ethical working

6)     Eye for details

7)     Sense of urgency and commitment to timelines and promises for work delivery

8)     Ability to maintain required business secrecy

9)      Provide leadership to team mates

Job Location : 1 Hour from Pune

Job Designation: Sr Executive QA
Job Industry: Pharma / Biotech / Clinical Research
Job Location: Pune
Job City: Pune
Job Country: India
Job Active: Active

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