Analytical QA Analyst
Bangalore, KA, IN, 560099
JOB DESCRIPTION
Job Role : Analytical QA Analyst
Department : Quality Assurance - BGRC
Job Location : Bangalore
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 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:
- The employee is responsible for the following activities:
- Responsible for online documentation adhering to GDP practices.
- Authorized to prepare quality assurance procedures.
- Attend mandatory training as and when conducted.
- Responsible for archival activities.
- Responsible for execution of daily QA activities and maintenance of area.
- Authorized to issue documents from EDMS and reconcile the same.
- Authorized for issuance and withdrawal of logbook, procedures, schedules, etc.
- wherever applicable and maintenance of issuance/ withdrawal records.
- Responsible for monitoring the usage of current approved procedures in all relevant departments.
- Responsible for overall management of training activities and handling of training.
- Authorized to perform training coordinator responsibilities as per procedure.
- Responsible for ensuring compliance with cGMP as laid down in the procedures.
- Responsible for ensuring safe operation within BGRC QA and accordingly to ensure zero safety incidents.
- Ensure to report safety incidents/ Near miss if any, and 100% safety related training compliance.
- Responsible for maintenance of QA SOP index and specimen signatures of new joiners.
- Responsible for escalating the abnormalities/ gaps in procedures if any, to reporting manager/ HOD or user department (where applicable).
- Responsible for execution and approval of ISO 17025:2017 requirements at BGRC. Any other assignment allocated by reporting manager and / or above.
Behavioural Skills
- Good Interpersonal skills
- Self-time management
- Good team player
- Good communication skills
Syngene Values
All employees will consistently demonstrate alignment with our core values
• Excellence
• Integrity
• Professionalism
Specific requirements for this role
Experience
• 2 to 6 years
Education
• M. Pharm/ M.Sc. (Analytical chemistry/Chemistry)
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.