Are you an experienced professional in the pharmaceutical industry looking to take your career to the next level? At CellBio HiMedia Life, we’re on the lookout for a dedicated QC Manager – Analytical Services to join our dynamic team. This is more than just a job; it’s a chance to be part of a company that values life sciences and brings innovations that matter. If you meet the qualifications and are ready to tackle new challenges, we want to hear from you!
Overview of the Role
As a QC Manager – Analytical Services, you will play a crucial role in ensuring our quality management system complies with Good Laboratory Practice (GLP) standards. Your responsibilities will encompass overseeing various critical functions including quality control of biological drug substances and facilitating related laboratory operations, with an emphasis on buffer preparation and both upstream and downstream processes.
Key Responsibilities
Implementing Quality Management System
Your primary focus will be to implement, maintain, and oversee a GLP-compliant Quality Management System. This includes:
- Quality Control: Ensure manufacturing and quality control processes adhere to applicable regulations and guidelines.
- Incident Management: Lead the closure and investigation of Out Of Specification (OOS) results, Out Of Trend (OOT) occurrences, deviations, and laboratory incidents as per established procedures.
- CAPA Management: Supervise the Corrective and Preventive Actions (CAPA) system to manage changes, deviations, and non-conformities effectively.
- Risk Assessments: Coordinate and support risk assessment initiatives to identify and mitigate potential quality issues.
Regulatory Inspections & Compliance
- Inspection Readiness: Ensure laboratory readiness for national and international regulatory inspections, including those from USFDA, UK-MHRA, EU, Local FDA, and NABL.
- Supplier Qualification: Manage the qualification processes for suppliers concerning materials and services to ensure quality compliance.
- Instrument Qualification: Support and review the qualification of instruments, test equipment, and cleanroom facilities.
- Batch Record Review: Review and approve batch records, ensuring the department meets turnaround time (TAT) targets.
Customer Engagement and Reporting
- Service Timeliness: Ensure timely services to customers and distribution channels through efficient communication management and participation in cross-functional projects.
- Document Review: Review GLP-related documents to maintain high compliance standards.
- Validation Activities: Oversee method validation, method transfer, and cleaning validation activities.
- Product Release: Responsible for the release of batches of biological intermediate products and related final products.
SOP Development
- Standard Operating Procedures: Prepare and review Standard Operating Procedures (SOPs) related to various functions.
- Additional Responsibilities: Undertake additional activities as assigned by the Head of Department (HOD) as needed.
Qualifications & Experience
To be considered for this exciting opportunity, candidates should possess:
- A Master’s degree in Chemistry, Pharmacy, or a PhD in a relevant discipline.
- A robust background with 15-20 years of experience in an analytical testing laboratory setting.
Why Join CellBio HiMedia Life?
At CellBio HiMedia Life, we believe “Life is Precious.” Join our team and contribute to life-enhancing research and development in the pharmaceutical industry. We offer competitive salaries, comprehensive benefits, and an inclusive work culture that fosters growth and innovation.
If you are qualified and ready to embrace the challenge, please send your CV to gvaidya@himedialabs.com and ats.hrd@himedialabs.com with the subject line “Application for Analytical Services – Sales.”
Job Location: Thane, Maharashtra
Company Website: www.himedialabs.com
Conclusion
This is not just a job listing; it’s your gateway to becoming part of a pioneering organization in the pharmaceutical sector. If you have what it takes to excel as a QC Manager – Analytical Services, we encourage you to apply today! The future of life-saving pharmaceuticals awaits your expertise.
