Title:  Senior Executive

JOB DESCRIPTION

Job Title: Analytical Chemistry-Analyst - ICP-MS/ ICP-OES

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 

Core Purpose of the Role:

• To oversee method transfer, validation activities related to elemental assay and trace analysis.
• Analysis and characterization of elemental impurities in trace and assay levels.

Role Accountabilities:

• Planning of day-to-day activities and reviewing of documents.
• To execute stability analysis, validations and method transfers on FES, AAS, ICP-OES and ICP-MS techniques as on required within timeline.
• Review of document generated on stability analysis, validations, method transfers and calibrations.
• Execution of validation protocols and routine analysis.
• Preparation of validation and stability protocols and reports.
• Preparations of SOPs, EOPs and IOPs and provide training whenever required.
• To prepare draft investigation report for the deviations, Incidents, OOC, and OOS.
• To ensure the entire instrument for intended use meets the 21 CFR part 11 compliance.
• To oversee the quality aspects of stability operations and ensure the compliance for stability testing and LIMS.

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:
2-4 years of relevant experience in Quality Control department/Analytical Development Lab.

TECHNICAL /FUNCTIONAL SKILLS:

• Should have very good communication skills & technical report writing skills.
• Should have hands on experience on ICP-MS/ ICP-OES/ AAS and FES and other wet analysis instrumentation.
• Should be familiar with cGMP and ICH guidelines.
• Good knowledge on US/EU pharmacopoeias and its recent updates.
• Should be through with stability operations.
• Should have good hands-on experience in execution of stability testing in line with ICH guidelines and strict adherence cGMP.
• Exposure to USFDA audits & thorough knowledge in maintaining the prerequisites in the implementation of 21 CFR Part 11 compliance will be treated as an added advantage.

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.