Title: Quality Control (Validations)
JOB DESCRIPTION
Job Title: Quality Control (Validations)
Job Location: Bangalore, Biocon Park
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
Core Purpose of the Role:
- To handle the Analytical Method Validations/Transfers and verifications in QC
- To involve in method transfer activities with development lab
- To assess the method suitability and robustness and reject the methods that are not suitable
- To involve in validations of analytical methods as per ICH guidelines
- To have an expertise in Bioanalytical methods viz. iCE (charged variants), Capillary Electrophoresis, Protein Content by SoloVPE, Chromatographic techniques
- To have an expertise on plate-based techniques viz. HCP, HCD, rPROA etc.
- To have an expertise in cell-based bioassay techniques
- To prepare/review validation/transfer and verification protocols
- To ensure validation/transfer and verification activities are in compliance to regulatory expectations and client requirements
- To handle the client interactions
- To handle regulatory audits
- To train and guide the newcomers
- To ensure all time readiness for audits
- To adhere to good laboratory practices
- Exposure to Digitalization (LIMS/ELN etc.)
- To handle any other roles specified by team lead
Role Accountabilities:
- Handling Method Analytical Method Validations/Transfers and verifications in QC as per ICH guidelines
- To prepare/review validation/transfer and verification protocols
- To ensure validation/transfer and verification activities are in compliance to regulatory expectations and client requirements
- To handle the client interactions
Leadership Capabilities
-Team handling
- Decision making
- Guidance to analysts
- Client intercations
Syngene Values
All employees will consistently demonstrate alignment with our core values
- Excellence
- Integrity
- Professionalism
Specific requirements for this role:
- Aggressive but assertive on task completion.
- High influencing skills to complete the task at hand.
- Ability to provide solutions for complex problems.
Demonstrated Capability-
- Knowledge on Biologics testing and compliance requirements.
- Subject Matter expert on the Guidelines/regulations pertaining to Biologics
- Exposure to validations/transfers/verifications
- Exposure to regulatory audits
Education
M. Sc. (Biochemistry/Chemistry)
Experience
09-12 years
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.