Medreich Limited, a renowned pharmaceutical company established in 1976, specializes in manufacturing both generic and branded drugs across various therapeutic areas. With a dedicated workforce of over 2,900 employees worldwide and a commitment to exceptional quality standards, we serve clients in 54 countries. Medreich Limited is recognized for its relentless pursuit of product superiority in every endeavor.
Position: Development Quality Assurance
Experience Required: 5 to 7 Years
Location: Bengaluru (Bommasandra)
Key Responsibilities
As a Development Quality Assurance professional, you will be responsible for:
- Reviewing Key Documentation:
- Formulation LNB
- Pre-formulation study report
- Master formula card
- Scale-up report
- Product development report
- Process Validation:
- Understanding and preparing/reviewing process validation protocols and reports
- Conducting hold time study protocols and reports
- Master Production Documents:
- Preparation/review of Batch Manufacturing Records (BMR) and Batch Packing Records (BPR)
- Quality Management System (QMS) Activities:
- Change control
- Deviation management
- CAPA and CAPA effectiveness
- Risk assessment
- Out of Specification (OOS) and Out of Trend (OOT) investigations
- Incident management
- Internal auditing
- Equipment Qualification
- Knowledge Management Systems:
- Document Management System (DMS)
- Laboratory Management System (LMS)
- SAP
- Regulatory Guidelines Compliance:
- Familiarity with ICH, EU-GMP, and Health Canada guidelines
Required Skills
- Proven experience in the review of development documents and validation protocols
- Strong understanding of QMS activities and equipment qualification
- Familiarity with DMS, LMS, and SAP systems
- Knowledge of regulatory guidelines
How to Apply
If you meet the qualifications and are interested in joining our dynamic team, please submit your resume to vineeta.k@medreich.com.
Note: DO NOT APPLY IF YOU ARE A FRESHER
Job Opening: Analytical Research & Development
Position: Officer, Executive, Research Scientist
Experience Required: 1 to 4 Years
Location: Bengaluru (Bommasandra)
Education Requirements:
- M. Pharm in Pharmaceutical Analysis
- M.Sc. in General Chemistry or Applied Chemistry
Key Skills
- AD/ADL/QC Validation: Expertise in formulation in Oral Solid Dosage (OSD)
- LCMS/MS Experience: Handling genotoxicity impurities
- Analytical Method Validation:
- Drug products and drug substance validation/development for Nitrosamines
- Analytical method transfer for Nitrosamines
- Stability analysis for Nitrosamines
- Calibration of LCMS/MS Systems
- Method Equivalency for drug products and drug substances
How to Apply
Interested candidates with the relevant experience are encouraged to submit their resume to vineeta.k@medreich.com.
Note: DO NOT APPLY IF YOU ARE A FRESHER
