Validation Engineer (Documentation)

Parle Global Technologies

2 - 3 years

4 - 6 Lacs

vasai

Posted:-1 days ago| Platform:

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Skills Required

oq iq equipment validation pq ifat product testing process validation validation testing pharma machinery product validation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Description:

The Candidate should have experience in preparation of IQ, OQ, DQ, PQ, FS documents, Service manual and machine QA check list.
The Candidate should have experience in Pharma packaging machines. Tablet counting and filling line machines. Liquid filling line machines and Standalone machines
The Candidates should read Machine GA, Layout, Pneumatic and Electrical drawing.
The Candidate Should have basic knowledge of cGMP compliance and GEP standards.
The Candidate should have basic knowledge of 21CFR PART 11 compliance and reports detailing.
The Candidate should be able to coordinate with Purchase and arrange required Test and MOC certificates.
The candidate should be aware of the basic interlocks and logical testing procedures.
The candidate should conduct the IFAT and share machine open points to the production.
The candidate should conduct the CFAT and share machine open points to the production.
The Candidate should check all compliance and prepare mandatory reports to give dispatch clearance.
The candidate should face ISO audit and maintain the required reports.
The candidate should clear the validation and all documentation part as per machine dispatch and validation Plan.
If needed, then the candidate should visit the site or support the regional engineer for the qualification support.

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