22/03 Mahendra Bhad
HR Manager at

Views:294 Applications:39 Rec. Actions:Recruiter Actions:0

Associate - Quality & Compliance - Pharma/Life Sciences (3-8 yrs)

Chennai/Pune Job Code: 2823

Job Description :

Level : Associate

CTC- max 11 LPA (incl 1 LPA var)

Location : Pune/Chennai

Education - Any Life Sciences/Pharma graduate.

JD below :

- Provide Quality & Compliance assurance services for the programs/projects that are under GxP purview

- Independent review of the project deliverables/change control documents

- Application Operation related SOPs, Work Instructions and give advice for continuous operational improvement

- Monthly metrics

- Training coordinator for the project team and Manage

- Provide guidance and support on client QMS to the project/application team

- Customization of the identified process on need basis.

- Knowledge of Audit and CAPA

- Maintain storage of all the hard copy project records (Hand annotated test results, training completion forms, etc.)

PFB the key skills to look for : 

- Computer System Validation experience must

-  Validation- consultant.

Below are the prescreening questions :

- As a validation consultant what is the key deliverable that you have authored?- (Validation plan (or document that contains - validation strategy- ).

- What does 21 CFR Part 11 regulation deal with ? - (Regulation deals with electronic records, electronic signature and audit trail.)

- Have you worked in GxP critical projects? - (answer should be - yes- .)

- What are the qualifications that we do when we stick to V-model? - (Installation Qualification, Operational Qualification and Performance Qualification)

Qualification : Any Life Sciences/Pharma graduate/BE/BTech/BSc/B Pharma

This job opening was posted long time back. It may not be active. Nor was it removed by the recruiter. Please use your discretion.

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