Medreich, a global pharmaceutical company, is hiring Quality Assurance professionals for their Pilot Plant in Hoskote, Bengaluru. Ideal for candidates with 5 to 9 years of experience in pharmaceutical quality systems and regulatory compliance.
Job Overview: Quality Assurance Professionals for Pilot Plant
As a Quality Assurance professional at Medreich, your responsibilities include implementing and maintaining pharmaceutical quality systems in line with company policies and regulatory standards. Your role focuses on ensuring that all products manufactured at the pilot plant meet the necessary cGMP requirements.
Key Responsibilities
- Candidate should have experience in review of the Formulation LNB, Pre-formulation study report, Master formula card, scale-up report, product development report.
- Candidate must have adequate knowledge on process validation concept and on preparation / review of process validation protocols / reports, hold time study protocols / reports.
- Preparation / review of Master Production documents (BMR, BPR).
- Knowledge on QMS activities (Change control, Deviation, CAPA, CAPA effectiveness, risk assessment, OOS, OOT, Incidents and Internal Audit).
- Knowledge on Equipment qualification.
- Knowledge on DMS, LMS and SAP.
- Knowledge on regulatory guidelines (ICH, EU-GMP and Health Canada).
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: Medreich’s Pilot Plant in Hoskote, Bengaluru.
How to Apply
If you are passionate about quality assurance and have the qualifications and experience to succeed in this role, please submit your resume to vineeta.k@medreich.com or prashanth.c@medreich.com.
https://pharmastuff.org.in/job/medreich-looking-for-quality-assurance-professionals
