Job Description

Designation: Senior Executive - Analytical Lab
Job Location: Bangalore
Department: Analytical - Baxter Global Research Center (BGRC)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

Job Purpose: Qualitative and quantitative analysis using LCMS or GCMS instrument.Essential Duties and Responsibilities:

• Independently and successfully execute experiments towards method development, method validation, specifically for extractable and leachable profiling studies, within specified timelines.
• Make sound technical recommendations in routine analytical activities. Provide analysis/redesign of key experimental procedures.
• Produce scientific experimental data based on written procedures like method of analysis, protocols etc.
• Involve in and conduct trouble shooting of analytical methods, laboratory investigations etc
• Provide input to select analytical techniques and procedures to solve problems within area of responsibility.
• Apply technical theories and principles to projects within area of expertise.
• Independently analyze and propose solutions to research challenges. Learn newer analytical techniques to enhance the capability and productivity.
• Author documents like Method of analysis/ protocols/ reports
• Perform/ provide support as needed in calibration and maintenance of equipment in the laboratory.
• Participate and take ownership of equipment installation and qualification activities as per Baxter's QMS.
• Document laboratory work performed per Baxter's GDP.
• Work according to appropriate quality standards and quality principle (e.g., Data Integrity, ALCOA)
• Follow Baxter's Quality Manual, SOPs, and Environmental Health, Safety & Sustainability (EHS&S) guidelines in day-to-day activities, to ensure proactive compliance and continuous improvement.

Behavioral Skills

• Good Interpersonal skills
• Self-time management
• Good Team player

• Polite/Good Communication skills

Syngene ValuesAll employees will consistently demonstrate alignment with our core values

• Excellence
• Integrity
• Professionalism

Specific requirements for this roleExperience

• Should have 3-6 years of experience in analytical lab

Skills and Capabilities:

• 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.\xc3\x98 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. Pharm/ M. Tech/ M.Sc.

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.

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