Syngene Careers | Chemistry Candidates Apply Now for Validation Team Lead
Mandatory expectation for all roles as per Syngene safety guidelines:
- Overall adherence to safe practices and procedures of oneself and the teams is aligned.
- Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards.
- Driving a corporate culture that promotes an EHS mindset and operational discipline at the workplace at all times.
- Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environmental, health, and safety (EHS) requirements at all times in the workplace.
- Ensure all assigned mandatory training on data integrity, health, and safety measures is completed on time by all team members, including oneself.
- Compliance with Syngene’s quality standards at all times.
Core Purpose of the Role:
This is an exciting opportunity to play a role in Syngene’s Corporate Quality Assurance. The role will provide exposure to new technologies. It gives a chance to think ahead and be prepared to take on new challenges.
Role Accountabilities
Responsible for monitoring the health of the Qualification/validation process and for the continuous improvement as per current regulatory expectations. Review/Approval of Qualification, Validation, Re-qualification documents and QMS activities in compliance to approved procedures. Identify, coach, and monitor the team’s development and improvement activities. Ensure compliance with the observations of an internal, client, or regulatory audit and provide a response or support for observation-related CQA function. Drive operational excellence projects for continuous improvement.
Syngene Values
All employees will consistently demonstrate alignment with our core values:
- Excellence
- Integrity
- Professionalism
Specific requirements for this role
Experience
- Experience in the Biopharmaceutical drug substances and drug products industry.
- Hands-on experience for handling the qualification of the equipment used in manufacturing Biopharmaceutical drug substances and drug products.
- Deep knowledge of the qualifications of HVAC, LAFs, Biosafety Cabinets, and autoclaves.
- Understanding of Temperature mapping.
- Taken up green belt Six Sigma projects.
Skills and Capabilities
- Expertise in handling qualifications and validations of Biopharmaceutical equipment.
- Capable of thinking scientifically to address complex problems and develop solutions.
- Work as a team and have a collaborative mindset.
- Good communication skills.
Education
- M.Sc/B.E with thorough knowledge of Equipment qualification and validation.
