Qa Analyst (Pharmaceuticals)

Voltech HR Services (VHRS)

3 - 5 years

0 Lacs

chennai

Posted:5 days ago| Platform:

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Skills Required

drug gmp quality assurance gxp

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Contract Manufacturing Quality Oversight

Monitor and ensure
GMP, GLP, and GHP compliance
at all
third-party/contract manufacturing sites
.
Review and approve:

Master manufacturing agreements
Quality agreements
Change control notifications

Ensure compliance with
Schedule M
,
CDSCO
,
FSSAI
(for nutraceuticals), and company quality standards.
Coordinate
vendor qualification and re-qualification audits
(initial, periodic, and for-cause).
Review and approve:

Batch Manufacturing Records (BMR)
Batch Packing Records (BPR)
Certificates of Analysis (COA)

Ensure proper
raw material, packaging material, and finished goods specifications
are followed.
Track deviations, OOS, OOT, and ensure
timely CAPA implementation
.

Preferred candidate profile

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