QC Analyst

Ritsa Pharma Pvt. Ltd

0 years

0 Lacs

hyderabad telangana india

Posted:3 days ago| Platform:

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Skills Required

qc data integrity audits audit documentation analysis stability calibration troubleshooting test compliance coordination

Work Mode

On-site

Job Type

Full Time

Job Description

Technical Expertise:

Hands-on experience with
HPLC, UV, IR, GC
instruments
Strong understanding of
GMP compliance
Knowledge and adherence to Data Integrity principles (ALCOA/ALCOA+)

Audits Faced:

Involved in facing regulatory and internal audits such as:
USFDA / MHRA / WHO / GMP / ISO
(mention whichever apply for the candidate)
Supported audit preparedness, documentation, and CAPA implementation

Roles & Responsibilities:

Performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
Operation, calibration, and troubleshooting of analytical instruments (HPLC, UV, IR, GC).
Preparation and review of analytical documents, SOPs, COAs, and test reports.
Ensuring compliance with
GMP
,
GLP
, and
data integrity
requirements.
Maintaining lab documentation as per ALCOA+ principles.
Handling OOS, OOT, deviations, and supporting investigations.
Participating in internal and external audits; ensuring audit readiness.
Maintaining good housekeeping, safety, and adherence to laboratory practices.
Coordination with cross-functional teams to ensure timely release of batches and samples.

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