Specialist Quality Stability Coordinator Job at MSD
MSD is hiring a Specialist, Quality (Stability Coordinator) to support global stability and external testing programs within a GMP-regulated pharmaceutical environment. This Quality Assurance Job role suits quality professionals with experience in stability data management, regulatory documentation, and quality systems, offering growth in a global hybrid work model. Graduates seeking for Pharma Jobs or Pharmacy job can apply for this Quality Assurance Job
Job Details:
- Job Title: Specialist, Quality (Stability Coordinator)
- Job Location: Pune, Hyderabad
About the Company:
MSD (Merck Sharp & Dohme) is a global research-driven biopharmaceutical company committed to improving health and well-being worldwide. MSD focuses on discovering, developing, and delivering innovative medicines and vaccines across a wide range of therapeutic areas, driven by strong values, scientific excellence, and a commitment to quality and patient safety.
Educational Requirements:
-
Graduation In Pharmacy Degree
Key Responsibilities:
- Compile and analyze stability data for integrated product stability programs
- Prepare stability-related regulatory documentation and conduct annual reviews
- Review batch-specific protocols (BSP) for compliance and accuracy
- Author Annual Stability Reports and stability sections of Annual Product Reports
- Act as change owner or initiator for change control activities
- Perform second-person reviews to ensure documentation accuracy
- Assist in creating and updating training materials for system changes
- Execute defined technical assignments independently
- Utilize LIMS, MS Word, Excel, and statistical tools such as JMP or Spotfire
- Support internal and customer audits at External Entities
- Manage stability schedules, trackers, forms, and ensure sample delivery to EEs
Skills Required:
- Minimum 2 years of experience in pharmaceutical or biotechnology quality roles
- Strong knowledge of Quality Systems, QA, and QC
- Understanding of global GMP and regulatory requirements
- Proficiency in written and spoken English
- Experience working in cross-functional teams
- Exposure to SAP, TrackWise, EDMS, and change control systems (preferred)
- Proficiency in LIMS/Labware and Microsoft Excel
- Strong documentation review, data analysis, and decision-making skills
- High accountability, adaptability, and interpersonal skills
- Graduates seeking for Pharma Jobs or Pharmacy job can apply for this Quality Assurance Job
