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JOB DESCRIPTION Job Title: Qualification/Validation Team Lead Job Location: Syngene International Limited, Bengaluru About Syngene : Syngene ( www.syngeneintl.com ) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines Overall adherence to safe practices and procedures of oneself and the teams 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 environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time by all members of the team including self Compliance to Syngene s quality standards at all times Core Purpose of the Role: This is an exciting opportunity to play a role in Corporate Quality Assurance of Syngene. The role will provide exposure to bring in newer technologies. It provides an opportunity to think ahead of time and be prepared to take up newer challenges. Role Accountabilities Responsible to monitor the health of Qualification/validation process and for the continuous improvement as per current regulatory expectation. Review/Approval of Qualification, Validation, Re-qualification documents and QMS activities in compliance to approved procedures. Identify, coach and monitor the team developments and improvements activities. Ensure compliance with the observations of an internal, client, or regulatory audit and provide 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 Demonstrated Capability Education Experience 12-15 years of experience in Biopharmaceutical drug substances and drug products industry. Handson experience for handling qualification of the equipment used in manufacturing Biopharmaceutical drug substances and drug products. Deep knowledge of qualifications of HVAC, LAFs, Biosafety Cabinets, 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 Equipment qualification and validation. Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.
