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 involves method development, method validation, method transfer and R&D stability studies by using laboratory instruments like Ultra performance liquid chromatography (UPLC), High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, Polarimeter, etc.
Role Accountabilities
Must have strong hands-on experience in development and validation of Assay & related substances methods for drug substance/drug product. Managing the stability studies for individual projects and stability data analysis, knowledge on stability guidelines and maintaining the sample storage.
Must have experience in handling HPLC, UPLC (Empower-3 software), GC, UV Visible spectrophotometer balances, Potentiometer, and stability chambers
Shall have experience on Good documentation/laboratory practices such as ALCOA+
Experience in calibration and qualification of HPLC, UPLC, GC, and other QC laboratory instruments
Shall prepare and review the raw data sheets, instrument operating procedures, and standard operating procedures
Shall have good experience in handling of QMS (such as incidents, Out of Specifications, Deviations, and Change control)
Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects
Shall adhere to the procedure of GxP/Safety and as per the procedure defined in the internal standard operation procedure
Shall operate the MS office (word, excel, ppt), outlook, and other essential tools required for routine activity
Good communication and e-mail writing skills are required since the candidate needs to communicate to client/external users situated overseas
Behavioral Skills
Good Interpersonal skills
Self-time management
Good Team player
Polite/Good Communication skills
Syngene Values
All employees will consistently demonstrate alignment with our core values
Excellence
Integrity
Professionalism
Experience
Specific requirements for this role
3-6 years
Skills And Capabilities
Hands-on HPLC, UPLC/UHPLC, CG, UV-Visible spectrophotometer, Potentiometer, and QC other analytical instruments
Theoretical knowledge in Chromatography and spectroscopy technique
Good documentation/laboratory practices such as ALCOA+
Able to follow work instructions and perform the tasks under the supervision of the Team leader
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