Posted:3 weeks ago|
Platform:
Work from Office
Full Time
1 Responsible for Planning and execution of Day to Day activities of SVP Plant for smooth operation in compliance to GMP.
2 Ensure appropriate qualification and availability of validation documents (URS, DQ, FAT/SAT, IQ, OQ and PQ) for the SVP plant
3 Ensure the execution of Qualification and validation activities and compilation of qualification and validation records
4 Ensure QMS documentation pertaining to the SVP plant activity.
5 Ensure execution of Engineering runs, Media fills and Production Batches
6 To review BMR, BPR in Caliber BRM software in absence of designee.
7 Handling of Caliber QAMS, DMS, Nichelon 5 CMS, Dynamic, serialization & aggregation.
8 Giving the required training, also responsible for handling of Quality Risk Management (QRM).
9 Responsible for Job allocation of Production Team.
10 To ensure the GMP at all level in the SVP plant.
11 To review Change Control, Incident /Deviations and ensure its closure, within given timeframe as per respective SOP.
12 To coordinate with warehouse team for ensuring the availability of raw material and packing material.
13 Ensure the execution of Process validation and equipment validation.
14 To inform top Management on quality issue (if any).
15 To ensure implementation of the CAPA initiated as a result of self-audit, customer, regulatory audit in production
Immediate joiners will be preffered. Interested candidates can share resume on dipika.parmar@milanlabs.com
Milan Laboratories
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