Corporate Investigation Lead

JOB DESCRIPTION

Job Title: CQA-Investigation Lead

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:

• The purpose of the role is to handle the Investigations across the Manufacturing and testing facilities as an SME and quality compliance in line with evolving regulatory expectations. Corporate governance for investigations across the organization.

Role Accountabilities

• Lead, mentor, and motivate the CQA Investigation team to meet company goals, maintain safety standards, and ensure high performance.
• Allocate investigation activities to the team, ensuring adherence to approved procedures and regulatory standards.
• Oversee the corporate investigation team s participation in critical investigations across GMP, GLP, GCP, Discovery, and Development verticals, ensuring depth and adequacy.
• Monitor closed investigations for compliance and adequacy in all verticals (GMP, GLP, GCP).
• Ensure continuous improvement of investigation processes in line with regulatory expectations.
• Train and qualify the personnel involved in the investigation across GxP verticals.
• Establish, monitor and maintain the investigation governance and excellence program across GxP verticals.
• Investigation of Data Integrity incidents, if any, and resolution.
• Conduct internal audits as a Subject Matter Expert for OUs and provide audit support.
• Ensure adherence to safety work standards and SOPs during investigation activities.
• Review and approve change controls, risk assessments, CAPAs, and SOPs.
• Present data for Quality Management Review meetings as required.
• Ensure timely completion of team training and qualification requirements.
• Provide training on investigation adequacy and related topics to the CQA team and other relevant stakeholders.
• Identify team development needs and create personalized development plans.
• Handle regulatory and client audits, support internal audits, and ensure compliance with KPIs.
• Liaise with department and OU heads to address risks identified in audits and ensure timely closure of QMS actions.
• Collaborate with site quality and manufacturing teams to resolve compliance issues.

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:

• About 16+ years of work experience in the pharmaceutical or biotech industry or CDMO sector.

Skills and Capabilities

• Technical knowledge in API, Biologics, and Formulations.
• Should have minimum 16 years of work experience in Pharmaceutical or biotech industry or CDMO sector.
• Life Science QMS procedures.
• Interpersonal skills to establish collaboration with cross-functional teams.
• Establish good Interpersonal skills with cross-functional teams.
• Capable of thinking scientifically to address complex problems and develop solutions.
• Work as a team and have a collaborative mindset.
• Good communication skills

Education

• M.Sc / M. Pharm/ B. Pharm/ MTech/B.Tech.

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.