Associate Consultant at Antal International Network
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General Manager - Quality Assurance - Oncology - Pharma (12-20 yrs)
Role: GM- Quality Assurance (OSD & Oncology)
Location - Baddi(Himachal Pradesh)
Job Description:
- Demonstrate Comprehensive leadership and management of Quality Management System (QMS)
- Design & demonstrate strong and visible support for the QMS and ensure its implementation throughout the Plant.
- Lead and build Empowered QA Teams and provide them continuous support in achieving quality output.
- Oversee the quality assurance operations and ensures that products are manufactured, tested released in a way that takes account of the requirements of cGMP and other regulatory requirements.
- Strong understanding of Injectables, aseptic work including disinfectants effectiveness, autoclaving, cross contamination GMP, media fills, sterility testing.
- Experience to deal with foreign consultants & inspectors
Must:
- Knowledge of current Good Manufacturing Practices, quality systems and quality assurance is required, along with working knowledge of manufacturing process steps and quality control for biologics product manufacturing, aseptic filling, utilities, and facilities.
- Sound technical skills including working knowledge of biologics and pharmaceutical production, quality assurance, and testing technologies.
- Experience complying with international regulatory standards.
- Experience with contract operations and implementation of quality systems
- Ability to diplomatically enforce Quality expectations.
- An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
- Strong commitment to individual and team development with particular emphasis on delivery of Quality Training.
- In ensuring that processes are established for capturing, documenting, communicating and measuring delivery against all customers- requirements.
- Timely completion projects.
Qualification - M.Pharma - Biochemistry/Microbiology/Life Sciences related field
Age - upto 45 yrs
Experience : Minimum 15 to 20 years of relevant experience in Sterile/Injectable
Preferred Industry - Any reputed Oncology Company
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