Title:  QC Group Leader

Job Title:  QC Group Leader

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 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:

This is an exciting opportunity to play a role in Quality control department of Syngene. The role will provide several responsibilities of Lab safety requirements and Compliance as per Syngene policy and EHSS requirement. It provides an opportunity to handle lab compliance and overall responsible for management of samples received in laboratory for analysis till release.

Role Accountabilities

1. 1. 1. 1. Overall responsible for planning of analytical team activities and release of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample/ Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples.
         2. Overall responsible for management of samples received in laboratory for analysis till release of same including reconciliation and destruction of left-over analytical sample.
         3. To ensure that Good Documentation Practices and Good Laboratory Practices are being followed by the employees within the team. To ensure that the data generated with respect to its authenticity, correctness, completeness and other aspects of data integrity as per Data Integrity policy.
         4. Review of protocols/ Reports/ specification/ preventive maintenance documents /Observation data sheet/temperature mapping etc.
         5. Review of documents and records related to routine operations in quality control. Review of documents in EDMS and TrackWise.
         6. Approval of user access requests, QC operations related requests, leaves, goals/ objectives and performance ratings as reporting manager.
         7. Review and assessment of proficiency & technical knowledge of employee and competency assessment of employees in QC laboratory.
         8. Interaction with cross functional team in QC department for timely completion of analytical activities.
         9. Check consignment documents like COA, MSDS, GRN, TRF, FTRF etc and monitor sampling of Raw materials, packing materials, In-process, Validation, finished products, water sampling and miscellaneous materials as applicable and certify the accuracy, adequacy and timeliness of the activity performed by analysts. Archive and retrieve documents related to the section.
         10. Outsourcing of sample based on requirement and updating respective Logbooks.
         11. Interaction with client and Project team for the smooth functioning of project related activities.
         12. Training of personnel in Quality Control.
         13. Involving in Investigation and closure of OOS, OOT, Laboratory incidences, deviation, CAPA and Non-Conformity as applicable.
         14. Review of QMS/Change Control in track wise and documents in EDMS as per requirement.
         15. Responsible for analytical deliverables on time with defined SLA/TAT.
         16. Responsible for ensuring all the procedural documents (SOP/IOP/GP) are prepared/updated as and when required.
         17. Maintenance and Calibration of Measuring and Testing Equipment/ Instrument belonging to the Quality Control Laboratory in coordination with Maintenance department.
         18. Responsible to coordinate with Engineering and Maintenance team and external vendor for Instrument qualification, preventive maintenance and calibration activities.
         19. Interaction with production, ADL, R&D, QA, regulatory, client and Project team and other stake holders for QC documentation related functions and smooth functioning of project related activities.
         20. Reviewing of RFP and analytical costing before sharing with BD and support in finalization of proposal for new projects.
         21. Reviewing LIMS/ELN relevant documentation, SOP’s, training presentations, and any other documents related to CSV requirement for any enhancements or new implementation/Modules. Collaborating with IT and QA to facilitate validation activities, writing/execution/review of Test Scripts, and effective implementation of LIMS. Ensuring the proper functioning of LIMS application as per the business needs through rigorous testing.
         22. Responsible for taking any other job allocated by Head QC / Group Leader.

Syngene Values

All employees will consistently demonstrate alignment with our core values

•  Excellence
•  Integrity
•  Professionalism

Specific requirements for this role

1. Experience
2. Demonstrated Capability
3. Education

Experience: 15+ years

Skills and Capabilities

Expertise in handling multiple activities in Pharmaceutical Industry.

Capable of thinking scientifically to address complex problems and develop solutions

Work as a team and have a collaborative mindset

Good communication skills

Education: MSC/ M. Pharma

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.