Head - QA Biologics at Syngene

, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

14 Mar, 26

Salary

0.0

Posted On

14 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Assurance, Biologics, Analytical Method Validation, Bioanalytical Method Validation, Microbiological Methods, Regulatory Inspections, Operational Excellence, Quality Management Systems, Data Integrity, Cross Functional Collaboration, Lean Six Sigma, People Management, Client Focus, Communication, Risk Management, Facility Qualification

Industry

Pharmaceutical Manufacturing

Description

JOB DESCRIPTION Job Title: Head – QA Biologics 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 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 incumber will also evaluate and implement sustainable operational excellence initiatives within 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. The incumbent shall oversee quality operations for Biologics Manufacturing Plant 1 (Mammalian) and Biologics Manufacturing Plant (Microbial) facilities. Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience: Acting as a Thought Leader with experience in QA/QC Biologics with at least few years of mid-to senior-level leadership experience within Quality department. Handled QC or QA operations within 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 on direct handling of regulatory inspections and client audits. Experience on operational excellence initiatives Demonstrated Capability: Handling diverse functions within Quality department with a deep understanding on 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, cross contamination strategy Excellent verbal and business communication Client focus Cross functional collaboration Lean Six Sigma – Black belt or Green Belt (preferred) Education: Master’s (Chemistry/Biochemistry/Microbiology/Biotechnology) or Ph. D Core responsibilities: Key responsibilities Quality To ensure implementation and sustenance of Data Integrity in all operations handled by 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) Overall responsible for ensuring 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 a continuous improvement of Quality Management Systems (Vendor Management process, IPQA, Quality Operations, Analytical QA) across Biologics Operational Unit Assessment of Quality of the investigations and QMS documentation related to 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, effectiveness of CAPA with individual Quality teams and recommend improvements in support of continual improvements and achieving world class standards/KPIs. Coordinating 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 Self inspection program. Act as Point of Contact for hosting inspections and audits from regulatory authorities, clients, and internal audit committees. Ensuring timely communication of responses to audit observations, CAPA and effectiveness to different stakeholders like regulatory agencies, clients, senior management, cross functional teams etc. To act as a consultant and advisor to 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 Analytical Quality Assurance team. Regulatory Ensuring right interpretation, communication, deployment of regulatory standards within Syngenes’ Quality Systems and processes to ensure compliance to reflect industry’s current thinking. People Identify, mentor and coach team members as part of people initiatives related to upskilling of staff, individual development plans, succession plans etc. General Work with the Head Quality to propose an Annual Operating Plan for the department Ensure the department operates within the approved Annual Operating Plan Delegate to Head of Quality Biologics in his absence. Perform any other task assigned by Head of Quality Biologics. 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.

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Responsibilities

The Head - QA Biologics is responsible for overseeing all Quality Assurance operations related to Biologics Manufacturing, including vendor management and compliance with quality standards. They will also facilitate continuous improvement of Quality Management Systems and ensure timely closure of QMS records.