Medreich, a leading pharmaceutical company with a global presence, is looking to expand its Quality Assurance (QA) team. They are currently hiring
Quality Assurance professionals for their
Pilot Plant in
Hoskote, Bengaluru. This opportunity is ideal for individuals with
5 to 9 years of experience in pharmaceutical quality systems, ensuring cGMP compliance, and handling regulatory audits.
About Medreich
Medreich is a well-established pharmaceutical company that offers a broad range of services, from R&D and manufacturing to regulatory support. With a strong commitment to quality and safety, Medreich has earned a reputation for delivering pharmaceutical products that meet international standards. Their facilities are compliant with the highest global regulations, making them a trusted partner for numerous clients worldwide.
Job Overview: Quality Assurance Professionals for Pilot Plant
As a
Quality Assurance professional at Medreich, you will be responsible for implementing and maintaining pharmaceutical quality systems in line with company policies and national and international regulatory standards. Your role will focus on ensuring that all products manufactured at the Pilot Plant meet the necessary cGMP (current Good Manufacturing Practice) requirements.
Key Responsibilities
- Oversee the effective implementation of pharmaceutical quality systems in compliance with company quality policies and regulatory requirements.
- Ensure that the products manufactured at the Pilot Plant meet all necessary cGMP and SOP (Standard Operating Procedure) standards.
- Review and authorize essential documentation, including SMF, SVMP, QMS documents (Change control, deviation, OOS/OOT, CAPA), process validation, equipment qualifications, cleaning validation, and more.
- Monitor the laboratory environment and ensure adherence to cGMP requirements.
- Ensure data integrity and proper data governance across all quality processes within the plant.
- Review and approve standard operating procedures, methods of analysis, and specifications.
- Lead regulatory/customer audits and handle CAPA (Corrective and Preventive Actions) complaints.
- Support validation and qualification activities, including report compilation for different data sets.
- Coordinate with customers and regulatory bodies on quality and technical matters.
Qualifications and Skills
- Educational Requirement: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or a related field.
- Experience: 5 to 9 years of experience in Quality Assurance within a pharmaceutical manufacturing environment.
- In-depth knowledge of cGMP, SOPs, process validation, and quality systems.
- Strong experience in handling regulatory and customer audits.
- Proficiency in using QLMS and SAP for material and process order releases.
- Excellent communication skills to collaborate with various departments, including R&D, regulatory teams, and external customers.
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Medreich Recruitment Notification[/caption]
Location
This position is based at Medreich’s
Pilot Plant in Hoskote, Bengaluru. The plant operates in compliance with international regulatory standards and provides an excellent work environment for professionals seeking to advance their careers in pharmaceutical quality assurance.
How to Apply
If you are passionate about quality assurance and have the qualifications and experience to succeed in this role, submit your resume to
vineeta.k@medreich.com or
prashanth.c@medreich.com.
https://pharmastuff.org.in/job/medreich-looking-for-quality-assurance-professionals
