QMS Engineer

Designation: Sr. Executive

Job Location: Bangalore

Department: Engineering and maintenance

About Syngene

Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose

To support and maintain the Quality Management System (QMS) in compliance with regulatory requirements, company policies, and industry best practices. The role involves documentation control, audit coordination, CAPA management, and continuous improvement initiatives.

Key Responsibilities:  

• Overall adherence to safe working practices and procedures of oneself and the teams assigned.
• Assist in the implementation and maintenance of QMS processes (Change Control, CAPA, Deviations, Document Control).
• Support internal and external audits by preparing documentation and coordinating with stakeholders.
• Maintain and update SOPs, policies, and quality records in the document management system.
• Track and follow up on CAPAs and audit findings to ensure timely closure.
• Collaborate with cross-functional teams to ensure compliance and quality improvements.

• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards.
• Conduct training sessions on QMS procedures and compliance requirements.
• Driving a corporate culture that promotes environment, health, safety and Sustainability (EHSS) mindset and operational discipline at the workplace always.
• Ensuring safety of self, teams, and lab/plant by adhering to safety protocols and following environment, health, safety and sustainability (EHSS) requirements always 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 always.
• Hold self and my team accountable for the achievement of safety goals.
• Govern and Review safety metrics from time to time.
• Adhere to the established procedures and policies of the company.

Educational Qualification:  

• B.E./B. Tech/ Diploma in Mechanical/Electrical/Instrumentation
• 4-6 years (Senior Executive) of experience in QMS within pharma/biotech/chemical industry.
• Knowledge of ISO standards, GMP, and regulatory guidelines (USFDA, EMEA, WHO).
• Proficiency in QMS software tools and document control systems.

Technical/Functional Skills:

• Preparation and review documents related to QMS and EHSS management system.
• Strong understanding of quality systems and regulatory compliance.
• Excellent documentation and communication skills.
• Analytical mindset with attention to detail.
• Ability to work independently and in cross-functional teams.
• Planning & execution of Validation activities.
• Preparation of individual unit master lists and updating of equipment between the defined period.

• Plan and support for executing new proposal requests like modification and new initiatives.

• Quality Management Systems (QMS):
  • Hands-on experience with QMS elements: CAPA, Change Control, Deviations, Document Control, Risk Management.
  • Familiarity with ISO 9001, ICH Q10, and other relevant standards.
• Regulatory Compliance:
  • Understanding of GMP, GLP, and regulatory guidelines (USFDA, EMEA, WHO).
  • Experience supporting audits and inspections.
• Documentation & SOP Management:
  • Strong skills in drafting, reviewing, and managing SOPs, policies, and quality records.
  • Proficiency in electronic document management systems (EDMS).
• Audit Handling:
  • Experience in internal/external audits, preparing audit responses, and tracking corrective actions.
• Data Analysis & Reporting:
  • Ability to analyse quality metrics, audit trends, and prepare dashboards or reports for management.

Behavioral Skills:

• Good communication skill, both verbal and written
• High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.

Soft and Digital Skills:

1. Attention to Detail:
• Precision in documentation and compliance activities.
2. Communication Skills:
• Clear and professional communication with cross-functional teams and auditors.
3. Problem-Solving:
• Root cause analysis and effective CAPA implementation.
4. Team Collaboration:
• Ability to work with engineering, production, and QA/QC teams.
5. Time Management:
• Prioritizing tasks and ensuring timely closure of quality events.

Digital Skills

• Familiarity with QMS software (Track Wise, EDMS and Validator).
• Proficiency in MS Office (Excel, Word, PowerPoint).
• Basic understanding of data visualization tools (e.g., Power BI) is a plus.

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.