LCMS GCMS

JOB DESCRIPTION

Job Title: Analytical Chemistry-Analyst - LCMS/ GCMS

Department: BGRC - Analytical
Job Location: Bangalore

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

Role Accountabilities:

• To perform method development and validation studies using LCMS or GCMS techniques.
• Extractables, Leachables, Nitrosamines studies using LCMS or GCMS.
• Responsible for preparation of test procedures, development reports, technical reports, validation protocols and reports.
• Abilities in qualification, calibration and troubleshooting of analytical instruments.
• To carry out the investigations in case of deviations, OOT, OOC OOS.
• To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
• Preparation review of SOPs, IOPs and EOPs and provide training whenever required.
• Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.
• 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

WORK EXPERIENCE:
Should have 6-8 years of experience in analytical lab

TECHNICAL /FUNCTIONAL SKILLS:

• To perform method development and validation studies using LCMS and GCMS techniques.
• To perform method development and validation studies using ICPMS as per USP ICH requirements.
• Extractables, Leachables, Nitrosamines studies using LCMS GCMS.
• Responsible for preparation of test procedures, development reports, technical
• reports, validation protocols and reports.
• Abilities in qualification, calibration and troubleshooting of analytical instruments.
• To carry out the investigations in case of deviations, OOT, OOC OOS.
• To ensure instruments are compliant to 21 CFR Part 11 requirements, wherever applicable.
• Preparation review of SOPs, IOPs and EOPs and provide training whenever required.
• Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.
• Must comply with GMP, data integrity EHSS practices.

Education

• M.Sc/M.Pharma

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 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.