QMS support lead

JOB DESCRIPTION

Job Title: QMS support lead (Level 2)

Job Location: Bangalore office, S20 Block 5th floor.

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:

1. Review, track, and approval of QMS elements (Deviations, Change controls, CAPA, Customer complaints) arising from manufacturing unit.

Role Accountabilities

1. Review and approve Change controls, risk assessments(product, process and facility) and investigations.
2. Collaborate with cross-functional teams to finalize change control reports and investigation reports
3. Participate in client calls to finalize investigation reports and change controls
4. Prepare trend reports for deviations, change controls, customer complaints, and CAPAs.
5. Track QMS elements to ensure timely closure.
6. Periodically compile and present QMS data to senior leadership/management.

Leadership Capabilities

Syngene Values

All employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Accountabilities as a Syngene Leader

• Champion effective Environment, Occupational Health, Safety and Sustainability (EHSS) practices for the company and oversee compliance with those practices within Biologics business. Play an active leadership role in monitoring and verifying safety performance through Gemba walks and other safety-led activities.
• Foster a corporate culture that promotes an environment, occupational health, safety, and sustainability (EHSS) mindset as well as the highest standards of quality, integrity, and compliance.

• Put people at the heart of our success by providing clear, active leadership defined by the Syngene leadership framework setting high standards of people management, career planning and talent retention as a priority.

Specific requirements for this role

Experience :

10 to 12 years of experience in biologics manufacturing, with a focus on Quality Assurance related activities involved in reviewing investigations, change control and various Quality Management System elements.

Demonstrated Capability:

1. Problem-solving mindset: Capable of developing actionable corrective and preventive measures (CAPAs).
2. Cross-functional collaboration: Strong communication skills to work effectively with diverse teams, including quality, operations, and regulatory groups.
3. Knowledge of regulatory guidelines: Familiar with ICH, FDA, EMA, 21 CFR and other global regulatory standards relevant to biological manufacturing.
4. Experience with QMS: Proficiency in using QMS tools for tracking deviations, CAPAs, and change controls, risk Management (product, process and facility)
5. Good documentation practices: Strong knowledge of data integrity principles and proper documentation procedures.
6. Decisiveness: Ability to make well-informed decisions swiftly, especially under time constraints.
7. Adaptability: Capable of managing multiple investigations simultaneously and adapting to changes in regulatory and company standards.
8. Leadership skills: Ability to guide teams through root cause analysis and process improvements.
9. Ethical and unbiased approach: Ensures investigations are thorough, impartial, and compliant with quality and regulatory standards

1. Education: Masters degree in a scientific or related field.

Skills and Capabilities:

Education

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.