Department: Early phase GMP - Analytical Development
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 always.
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 Description: Performing analytical method validations and related documentation, as well as analysis of RM, PM, Intermediates, API, and Finished products.
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Performing Chromatographic and Non-chromatographic analysis for Drug substances, Drug products, Intermediates, Excipients, etc…).
Conduct the analysis on qualified techniques per the approved specification/protocol/procedures, interpret the data from analytical instruments, report the results, and promptly submit the completed documents for review within the established window.
Recording of analytical observations/findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS, and ELN application software, and support in preparing stability summary reports and review of final documents.
Responsible for timely intimation/investigation of any events or deviations to the Department Head, QA function, supporting the related investigations to the clients, and timely closure.
Instrument calibration as per schedule, hot water flushing of HPLC, and general preventive checks for laboratory instruments.
Perform validation activities and method transfers for multiple client projects.
Actively participate in client and regulatory audits. Ensure to follow cGMP and GDP.
Preparing the certificate of analysis for standards and impurities and Reports for Analytical Method Validation and Analytical Method Transfer.
Support in performing Qualification and Calibration of assigned Instruments and Equipment.
Create/prepare documents, master data, and static data in LIMS, ELN, and LMS software as applicable.
Outsourcing of sample testing is based on requirements and updating in respective logbooks.
Coordination with engineering & maintenance and external vendors for preventive maintenance and calibration activity.
Support in preparation of instruments URS, DQ, and IOP.
Supported preparing standard operating procedures and uploading data in LIMS and other relevant activities per departmental requirements.
Use of required safety PPE while sampling, analyzing, and working in the Laboratory.
Individuals working in the GMP environment are responsible for documenting/recording the activities contemporaneously and accurately as per good documentation practices.
Ensure safety compliance as per Syngene policy and EHSS requirements.
Taking any other jobs by the Head QC/Group Leader/Designee.
To ensure safety compliance as per Syngene policy and EHSS requirements.
Educational Qualification: M Sc / M Pharma (Analytical/General chemistry)
Technical/Functional Skills:
Should be well versed with the latest analytical techniques like HPLC/GC, KF/KFC, IR/UV, LC-MS, GC-MS, IC, ICP-OES/ICP-MS, DSC, TGA, etc...
Being well-versed in the Chromeleon data management application and LIMS will be advantageous.
Experience: Foundational
Behavioral Skills:
Should be an adaptive learner.
Should demonstrate effective Communication skills.
Organization and ability to balance work and Life.
Should possess good Time Management abilities.
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 about 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.
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