QMS Coordinator

Job Title: QMS Coordinator

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 pivotal role in driving quality excellence at Syngene through the QMS function. The role offers exposure to implementing cutting-edge quality practices and refining compliance workflows, ensuring operational efficiency and regulatory readiness. It provides a platform to proactively identify improvement areas, embed quality culture across functions, and stay ahead of evolving standards in Formulations.

Role Accountabilities:

Drive the continuous enhancement of Syngene’s Quality Management System by developing robust, in-house processes that reduce dependency on external audits and consultants. Begin by performing an in-depth review of existing QMS frameworks and regulatory guidelines. Design and implement optimized quality workflows leveraging digital tools and risk-based thinking. Evaluate system effectiveness through CAPA trends, and compliance metrics to identify process improvement hotspots. Based on these insights, the QMS evolved to support readiness for global regulatory expectations.

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:

• Candidate should have 9 -12 years exposure in Oral  Solid Dosage forms and injectable facility quality assurance activities.
• Candidate should have USFDA audit exposure.
• Establish good Interpersonal skills with cross-functional teams.

Skills and Capabilities:

Expertise in handling multiple expression platforms

Capable of thinking scientifically to address complex problems and develop solutions

Work as a team and have collaborative mindset

Good communication skills

Education:

B. Pharm/ M. Pharm

Job Description:

Key Responsibilities: 

• Create/ revise procedures and other related documents as applicable.
• Review of SOPs, IOPs, EOPs, Protocol and Reports for Formulation Facilities.
• Handling of Change Controls, Deviations, CAPA, Customer complaints, Self-Inspection and Internal Quality Audit.
• Perform Trending of Change Controls, Deviations, CAPA, LIR and Customer complaints.
• Ensure compliance with observations of Self Inspection, Internal Quality Audit and client or regulatory audit.
• Perform activities related to SAP.
• Vendor qualification of raw material, packing material, consumables, contractors engaged in manufacturing pertaining to GMP manufacturing with respect to vendor questionnaire verification, vendor audit and compliance report verification for approval.
• Approval of vendors by desktop and site audits. (As required)
• Review of Risk assessment document from the vendor.
• Verification of vendor rating documents from the purchase.
• Inspection of RM, PM and consumables for any damage and discrepancy possible during receipt, storage dispensing and handling of these materials in warehouse.
• Review of vendor Quality Agreement.
• Preparation and updation of requalification schedule for Manufacturers.
• Archival of documents.
• Issuance of annexures and logbooks.
• Provide data for QMR and QGF meeting.
• Provide line clearance to Dispensing, Manufacturing and Packaging area.
• Provide dispatch clearance for Shipment.
• Preparation & Review of RSG report.
• Review and Approval of Calibration Certificate.
• Review of executed BMR and BPR.
• Responsible for review and release of Batches.

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.