Executive QMS- API

6.00 to 11.00 Years Mysore 21 Dec, 2020

Job Location	Mysore
Education	Not Mentioned
Salary	Not Disclosed
Industry	Recruitment Services
Functional Area	General / Other Software
EmploymentType	Full-time

Job Description

Roles and Responsibilities

Will work on Equipment s like HPLC, GC-HS, ICP-MS and LC-MS.
Preparation and revision of SOP s, STP s, IQ/OQ/PQ Protocols.
Preparation of validation protocols and Validation reports, and revision of schedules for Calibration.
Review and implementation of Pharmacopeia changes.
Training the team as per training calendar.
Handling of QMS Documents as Investigation of OOS / OOT,Deviation, CAPA, Change control, Lab incident / events.
Issuance of checklist, SOP s, log sheets, other records for data entry etc.
Involvement in audit compliance and regulatory submission and 21 CFR compliance.

Desired Candidate Profile

M.Sc in M.Sc.Org / Analytical/ Pharma Chemistry
Minimum 6 years and Maximum of 11 years in an API Pharma company
Karnataka based candidates with knowledge of Kannada
Must be experienced in handling the Equipment s like HPLC, GC-HS, ICP-MS and LC-MS.
Experienced in the preparation of SOP, STP and validation protocol,
Experienced in updating the documents as per the pharmacopeiachanges

Keyskills :
data entrychange controlaudit compliancevalidation reportsstpsopoosootcfrcapapharmakannadacontrolrecordstrainingprotocolequipmentprotocolscomplianceicpms

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Executive QMS- API

Job Description

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