Principal Scientist - Analytical

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

Job Purpose To ensure Quality Control laboratories remain inspection-ready and compliant with cGMP, GLP, Data Integrity, and global regulatory requirements. The role is responsible for managing QC compliance systems, Qualifications, supporting regulatory inspections and customer audits, investigating quality events, and driving continuous quality improvements.

Key Responsibilities

QC Compliance Management •Ensure compliance of QC laboratory activities with cGMP, GDP, GLP, ALCOA+, and Data Integrity requirements. •Review laboratory documents, SOPs, protocols, reports, specifications, and analytical records. •Drive periodic compliance reviews and gap assessments within QC operations. •Monitor adherence to internal quality systems and regulatory requirements.

Regulatory & Customer Audits •Provide leadership and support during external audits performed by regulatory bodies, including FDA and MHRA, as well as audits conducted by partners, customers, and other auditing bodies. •Act as QC subject matter expert during audits and inspections. •Prepare audit responses and coordinate closure of audit observations. •Track commitments and effectiveness of implemented actions.