QMS Expert

JOB DESCRIPTION

Job Title: Quality Management System (QMS) expert, expertise in QC and QA Investigations

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 role is quite a challenging and exciting opportunity to get involved in the review process of incident investigations triggered from QMS (Like OOS, OOT, Complaints, Deviation, and Laboratory Incidents). The purpose of this role is to ensure the adequacy of the investigations submitted by the user department, in such a way that it withstands any regulatory inspection or client audit. This role requires regular interactions and close working with the cross-function team members to brainstorm and identify the root cause of the observed incidents.

Role Accountabilities

Involvement in investigating identified Non-conformity (Deviation/OOS/OOT/Complaint etc.), and proposing the appropriate CAPA, and ensuring its implementation. Preparation and review of QMS Trends (Deviation, LIR, OOS, OOT, Change control Complaints). Follow GMP, GDP, and GLP procedures as applicable, while performing the assigned tasks. Preparation/revision/review of procedures (like SOP, protocols, calibration schedule, and other related documents as applicable). Ensure compliance with the observations of an internal, client, or regulatory audit. Involvement in the monthly and fortnightly quality review meetings.

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

Minimum 8 Years of experience in Handling QMS events

Had handled investigations related to date integrity.

Experience in organizing and hosting brainstorming sessions as part of the QMS investigation.

Expertise in handling and responding to the observations of an internal, client, or regulatory audit.

Responding to the observations from CQA surveillance.

Skills and Capabilities

Expertise in handling different kinds of QMS reported from multiple functions.

Capable of addressing complex problems and developing solutions along with CFT

Work as a team and have a collaborative mindset

Good communication skills

Excellent investigation review and writing skills

Education

Bachelor/ Master degree in pharma or chemistry.

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.