Senior Quality Management System Executive
Nalagarh, Himachal Pradesh, India · Full Time
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- Experience
- 4–12 yrs
- Salary
- INR 500,000 – INR 1,000,000 / year
- Openings
- 1
- Posted
- há 4 horas
- Work mode
- In office
- Education
- B.Pharm
- Eligibility
- Candidates with a B.Pharm degree in any specialization are eligible to apply.
- Resume
- Required to apply
Where you'll work
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Job description
Overview
Mediature GxP Solutions Pvt. Ltd. (MGS) is a prominent GMP and regulatory consulting firm dedicated to assisting pharmaceutical and healthcare companies in meeting compliance standards, enhancing quality systems, and achieving regulatory excellence.
Key Responsibilities
The role focuses on managing Quality Management System (QMS) activities including developing and maintaining Standard Operating Procedures (SOPs), Quality Manuals, Site Master Files (SMF), and other critical QMS documents. The candidate will conduct GMP gap analyses, prepare for audits ensuring optimal readiness, apply Quality Risk Management principles, uphold Data Integrity standards, and ensure compliance with various regulatory requirements.
Candidate Profile and Requirements
The candidate must have between 4 to 12 years of hands-on experience in QMS within pharmaceutical or related industries. Academic qualifications include a bachelor's or master's degree in Pharmacy or Life Sciences. Comprehensive knowledge of global regulatory standards such as WHO-GMP, USFDA regulations, EU-GMP, and Schedule M is essential. Exceptional skills in technical writing and thorough documentation practices are required to produce high-quality compliance documentation.