Senior Analyst

JOB DESCRIPTION

Designation: Senior Analyst
Department: Method Validation & Special Instruments (Analytical Development)
Job Location: Bangalore

About Syngene

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 Expectations for All Roles as per Syngene Safety Guidelines

• Overall adherence to safe practices and procedures for self and aligned teams.
• Contribute to the development of procedures, practices, and systems that ensure safe operations and compliance with company integrity and quality standards.
• Drive a corporate culture that promotes an Environment, Health and Safety (EHS) mindset and operational discipline at all times.
• Ensure safety of self, team members, and laboratory/plant by adhering to safety protocols and EHS requirements.
• Ensure completion of all mandatory trainings related to data integrity, health, and safety by self and team members within stipulated timelines.
• Ensure compliance with Syngene quality standards at all times.
• Hold self and team accountable for achieving safety goals.
• Govern and review safety metrics periodically.

Job Description

Perform analytical method validations and related documentation, as well as analysis of raw materials (RM), packing materials (PM), intermediates, APIs, and finished products.

Key Responsibilities

• Perform chromatographic and non-chromatographic analysis for drug substances, drug products, intermediates, excipients, and related samples.
• Conduct analysis using qualified techniques as per approved specifications, protocols, and procedures; interpret analytical data, report results, and submit documents for review within established timelines.
• Record analytical observations and findings in observation data sheets, forms, logbooks, LIMS, and ELN applications; support preparation of stability summary reports and review of final documents.
• Promptly report and support investigation of deviations, incidents, and out-of-trend events in coordination with QA, department heads, and clients.
• Perform instrument calibration as per schedule, hot water flushing of HPLC systems, and routine preventive checks of laboratory equipment.
• Execute analytical method validation and method transfer activities for client projects.
• Participate in client and regulatory audits and ensure compliance with cGMP and GDP requirements.
• Prepare Certificates of Analysis (CoA) for standards and impurities and generate analytical method validation and analytical method transfer reports.
• Support qualification and calibration activities for assigned instruments and equipment.
• Create and maintain documents, master data, and static data in LIMS, ELN, and LMS systems.
• Coordinate outsourcing of sample testing activities and maintain related records and logbooks.
• Work closely with Engineering, Maintenance teams, and external vendors for preventive maintenance and calibration activities.
• Support preparation of URS, DQ, and IOP documentation for laboratory instruments and equipment.
• Assist in preparation and revision of SOPs and upload relevant data into LIMS and other applicable systems.
• Use appropriate safety PPE while sampling, analyzing, and working in the laboratory.
• Maintain contemporaneous, accurate, and compliant documentation in accordance with Good Documentation Practices (GDP).
• Ensure compliance with Syngene safety policies and EHSS requirements.
• Undertake any additional responsibilities assigned by the Head QC, Group Leader, or designated supervisor.

Educational Qualification

M.Sc. / M.Pharm (Analytical Chemistry / General Chemistry)

Technical / Functional Skills

• Strong hands-on experience with analytical techniques such as HPLC, GC, KF/KFC, IR, UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, and related technologies.
• Knowledge of Chromeleon data management application and LIMS will be an added advantage.

Experience

1 to 6 years

Equal Opportunity Employer

Syngene is committed to providing equal employment opportunity (EEO) to all applicants and employees regardless of age, colour, national origin, citizenship status, disability, race, religion, creed, gender, sex, sexual orientation, gender identity or expression, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. Reasonable accommodations will be provided for qualified individuals with disabilities.