Senior Associate Scientist - QA (02292018) Navi Mumbai, India
Role:
Quality assurance associate scientist will provide support, consultation and recommendations to project teams and other personnel. Scientist will be responsible to maintain the documentation in line with the Quality Management System including review and maintenance of documents as per various health authority requirements and expectations. Shall be responsible for compliance activities for Pharma science. This is an individual contributor role with no supervisory responsibility.
Typical work activities:
The work of the quality assurance associate scientist is likely to include the following activities:
- Continued maintenance of the Zoetis Quality Management System and overseeing the day-to-day
tasks within the Quality Assurance department.
- Handling of Quality Management System documentation like change control, deviation, incident, OOS/OOT etc.on routine basis, independently and maintain the track records. Preparation of QMS trending.
- Reviewing SOPs, Zoetis Quality System ( Global Operating Procedures) and maintain SOP Administration for the site.
- Reviewing batch manufacturing records (master and executed) & stability study data which is generated in house / received from CMO/ CRO.
- Act as training coordinator from QA. Responsible for maintaining training compliance status. Arrange GMP trainings & maintain the training documentation and track records.
- Responsible for coordinating and participating in self inspection.
- As needed, participate in external and internal audits to ensure compliance.
- Provide support to Regulatory CMC
- Maintain the document archival system.
- Documentation maintenance , archival and support.
- Communication with global team .
Knowledge/Experience Desired:
Master or Bachelor's Degree or equivalent in Life Sciences,Chemistry, Pharmacy and Engineering with 6-7years relevant experience in the Quality Assurance.
Self Motivated individual with good communication, well versed with Quality Management System. Ability to work in interdisciplinary and/or cross-cultural teams. Candidate must be able to quickly adapt to changing work scinarios. Thorough understanding of development activities and processes in pharmaceutical industry. Good time management, and decision making skills.