Overview
Quality Assurance Manager Jobs in Pune, India at HINDCO Consulting Services
JOB OVERVIEW:  The role involves providing remote  Quality Management System (QMS) support  , focusing on the management of OOS investigations, laboratory incidents, deviations, and change controls. Responsibilities include drafting and reviewing documentation, ensuring compliance with regulatory standards, and recommending continuous improvements.
KEY STAKEHOLDERS:
INTERNAL – Site Quality Team (QC, QA), Corporate Functions
EXTERNAL – Regulators (during inspection), Solution Providers
REPORTING STRUCTURE:
Site Quality (Functionally) & Central Quality-Document, Data Review & Creation(Admin)
QUALIFICATION:
B. Pharm / M. Pharm / M.Sc. Chemistry /
B.Sc. Chemistry or equivalent/Microbiology
EXPERIENCE:
• Over 10 years of QC/QA experience in regulated pharmaceutical companies.
•
Hands-on experience
in reviewing OOS, OOT, and lab incident investigations, as well as carrying out investigations, initiating change controls, and managing deviations.
•
Hands-on experience
in reviewing of APQR.
• Strong knowledge of applicable regulatory requirements (USFDA, EU & Health Canada)
•
Up-to-date
awareness of the latest regulations and pharmacopeial standards.
• Proficient in Current Good Laboratory Practices (cGLP) and QC instrumentation.
• Demonstrated experience in coordinating with customers and site management teams for the closure of QMS.
• Excellent organizational skills with a focus on detail and commitment to quality.
• Strong verbal and written
communication skills
, with the ability to collaborate effectively within a
team environment
.
Title: Quality Assurance Manager
Company: HINDCO Consulting Services
Location: Pune, India
Category: Quality Assurance – QA/QC (Data Analyst), Healthcare (Data Scientist)
