Quality & Compliance - Pharma/Life Sciences

ProvideQuality & Compliance assuranceservices for the programs/projects that are underGxP 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

Working Days :5 Days a Week ( to )