Senior Executive

2 weeks ago

bangalore, India Syngene Full time

Job Role: Senior Executive - Analytical R&D
Department : Analytical - BGRC
Job Location : Bangalaore

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:

Ø Preparation & Review of URS/IQ/OQ/PQ documents and ensure the adequacy and quality of documents.
Ø To perform & ensure method development/ familiarization / validation studies using ICPOES, AAS, HPLC, GC techniques per USP & ICH requirements.Ø Responsible for the preparation of test procedures, development reports, technical
reports, validation protocols and reports.
Ø Abilities in qualification, calibration and troubleshooting of analytical instruments.
Ø To carry out the investigations in case of deviations, OOT, OOC & OOS.
Ø To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
Ø Preparation & review of SOPs, IOPs and EOPs and provide training whenever required.
Ø Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.
Ø Must comply with GMP, data integrity & EHSS practices

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

Specific requirements for this role

Experience

• 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
• Preparation and Maintenance of all the documents
• Good knowledge of MS-office (word, excel, ppt) 

Education 

• M. Pharm/ M. Tech/ M.Sc. / B.Sc. (Analytical chemistry/Chemistry) with 3-6 years

Equal Opportunity Employer:  It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, 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.

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