Job Description

Job Title : Specialist Development QA_Development BiologyDepartment : Discovery and Development QAJob Location: Bengaluru, IndiaAbout Syngene : Syngene ( ) 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 spiritMandatory 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 trainings 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
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time

Core Purpose of the Role :Responsible for Quality Systems of Biopharmaceutical development Functions and relevant QA activities.Role Accountabilities

• Review and approval of laboratory Change control, deviations, investigations and CAPA in Track wise.
• Tracking CCF, deviation and incident closure status on weekly basis to achieve quality KPIs.
• Review and approval of SOP, IOP, OCP and EOP.
• Handling of customer projects and to ensure that the documents are reviewed and approved.
• Having experience in Biopharmaceutical Analytical, handling QMS and Process knowledge
• Perform self-inspection of BUs as per schedule.
• Review of Audit trials of application software instruments and electronic lab notebook (eLN).
• Review and approval of Instrument qualification and scheduled calibration documents.
• Coordinating with the laboratory personnel in handling of the customer queries.
• Issuance of workbooks and logbooks.
• Review of regulatory submission documents if any.
• Ensuring training compliance in line with training procedure and role-based curricula.
• Ensure lab compliance with respect to the laid down quality systems.
• Review and approval of analytical documents, comprising of chromatographic data files, Lab Notebooks, eLN.
• Review and approval of computerized system validation documents.
• Review and approval of Instrument qualification and scheduled calibration documents.
• Coordinating with the laboratory personnel in handling of the customer queries.
• Approval of validation/qualification documents as required.
• Other responsibilities as assigned by the reporting manager.

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Experience

• 08-12 years of relevant experience

Skills and Capabilities

• Team player, Result oriented and focus.

Education

• Bachelor pharmacy / Master\'s degree in pharmacy / Science

Equal Opportunity EmployerIt 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.

Syngene International