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