QMS Engineer

• 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.

• 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.

• 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.

• 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.

• Precision in documentation and compliance activities.
• Communication Skills:

• Clear and professional communication with cross-functional teams and auditors.
• Problem-Solving:

• Root cause analysis and effective CAPA implementation.
• Team Collaboration:

• Ability to work with engineering, production, and QA/QC teams.
• Time Management:

• Prioritizing tasks and ensuring timely closure of quality events.

• 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.

Syngene International