Syngene Careers: QA Jobs in Bangalore | MSc Chemistry Graduates Apply Now
Are you looking for senior QA Jobs with a leading innovation-driven biopharmaceutical organization? Syngene Careers is hiring for the position of Head – QA Biologics in Bangalore. This leadership role is ideal for experienced professionals seeking MSc Chemistry Jobs at a strategic level, offering responsibility for Quality Assurance operations across mammalian and microbial biologics manufacturing facilities.
About Syngene
Syngene International Limited is a leading global CRDMO supporting pharmaceutical and biotechnology companies from discovery through commercial manufacturing. Syngene Careers offers senior-level QA Jobs for professionals with strong regulatory and biologics expertise. This role is particularly suited for experienced leaders with MSc Chemistry Jobs backgrounds seeking impactful positions in biologics quality assurance and compliance.
Details
Job Title: Head – QA Biologics
- Location: Bangalore, KA, IN, 560099
- Division: Essential Functions
- Education: Master’s in Chemistry
Mandatory expectations for all roles as per Syngene safety guidelines:
- Overall adherence to safe practices and procedures of oneself and the teams is aligned.
- Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the company’s integrity and quality standards.
- Driving a corporate culture that promotes an environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
- Ensuring the safety of self, teams, and lab/plant by adhering to safety protocols and following environmental, 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 oneself.
- Compliance with 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 the Quality Assurance team – Biologics Business Unit of Syngene. The role will provide exposure to overseeing Quality Assurance operations for the Mammalian and Microbial manufacturing plants. The incumbent will also evaluate and implement sustainable operational excellence initiatives within the Quality Assurance department.
Role Accountabilities
The incumbent shall oversee all Quality Assurance operations, like Analytical Quality Assurance (Analytical, Bioassay, and Microbiology), Engineering Quality Assurance, Manufacturing Quality Assurance (IPQA), Quality Management Systems, Vendor Quality Management, Audits, and Compliance sections.
Experience:
- Acting as a Thought Leader with experience in QA/QC Biologics with at least a few years of mid to senior-level leadership experience within the Quality department.
- Handled QC or QA operations within the Biologics quality department.
- Hands-on experience in executing Analytical and Bioanalytical method validations, method transfers, testing, and release, stability operations.
- Knowledge on execution and validation of Microbiological methods.
- Experience in direct handling of regulatory inspections and client audits.
- Experience in operational excellence initiatives.
Demonstrated Capability:
- Handling diverse functions within the Quality department with a deep understanding of facility qualification, method validations, testing, and release, stability testing. Along with these technical skills, the incumbent must be experienced in deploying Operational Excellence measures and people management.
- Rich knowledge on regulatory guidelines, Quality risk management, and cross-contamination strategy.
- Excellent verbal and business communication.
- Client focus.
- Cross-functional collaboration.
- Lean Six Sigma – Black belt or Green Belt (preferred).
Core responsibilities:
Quality
- Ensure implementation and sustenance of Data Integrity in all operations handled by the Quality Assurance Team.
- Overall responsible for all Quality Assurance activities related to Vendor management, Quality Management Systems, In-process Quality Assurance, Analytical Quality Assurance (covering QC Biologics and QC Microbiology – Large Molecules).
- Ensure adequate staffing and training of personnel for Quality Assurance operations.
- Periodic review and presentation of Quality Metrics, Management Information System (MIS) reports, Org initiatives like Risk registers, people initiatives.
- Facilitate continuous improvement of Quality Management Systems (Vendor Management process, IPQA, Quality Operations, Analytical QA) across the Biologics Operational Unit.
- Assess the Quality of the investigations and QMS documentation related to the Biologics Operational unit.
- Ensure and facilitate timely closures of all QMS records like Change controls, out of specifications (OOS), Out of Trends (OOT), Deviations, Corrective actions and Preventive actions (CAPA), Laboratory Investigation reports (LIRs), and review trends, root causes.
- Review QMS trends, root causes, CAPA plans, and effectiveness of CAPA with individual Quality teams and recommend improvements in support of continual improvements and achieving world-class standards/KPIs.
- Coordinate with cross-functional teams like Manufacturing, Engineering and Maintenance, Warehouse, Strategic Sourcing, Corporate Quality Assurance, Internal Audits and Continual Improvement, Development and Discovery Quality Assurance, and other GxP functions for the implementation of Quality Management Systems (QMS).
- Liaise with customers, project management team, and senior management on project review meetings.
- Ensure facilitation of review and approval of Manufacturing records like BMR, PDR, Specifications, Test methods, Technology Transfer Documents, Batch release documents, Certificate of Analysis, Certificate of Conformity by proper planning of required personnel as per need.
- Review and approval of QMS documents like Quality Manual, Site Master Files, Validation Master Plans, Quality Agreements, SOPs, etc., as per Syngene’s standard.
- Conduct GMP rounds and implement the Self-inspection program.
- Act as the Point of Contact for hosting inspections and audits from regulatory authorities, clients, and internal audit committees.
- Ensure timely communication of responses to audit observations, CAPA, and effectiveness to different stakeholders like regulatory agencies, clients, senior management, cross-functional teams, etc.
- Act as a consultant and advisor to the Analytical Quality Assurance Team on improvement and simplification in operational aspects, including review processes (batch release testing, stability testing, data and audit trail review, computer system lifecycle for Quality control labs, etc.).
- Periodic review of QMS trends, CAPA, and effectiveness checks related to QC labs (Biologics and Microbiology) in coordination with the Analytical Quality Assurance team.
Regulatory
- Ensure the right interpretation, communication, and deployment of regulatory standards within Syngene’s Quality Systems and processes to ensure compliance with the industry’s current thinking.
