MPharma Job Syngene: Senior Executive Role! Apply Now!
Title: Senior Executive
Date: 25 Sep 2024
Job Location: Bangalore
Pay Grade: 9-I
Year of Experience: 0 – 3 Years
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 expectations for all roles as per Syngene safety guidelines:
- Overall adherence to safe practices and procedures of oneself and the teams aligned.
- Contributing to the development of procedures, practices, and systems that ensure safe operations and compliance with the 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 with 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.
- Execute stability analysis, validations, and method transfers on FES, AAS, ICP-OES, and ICP-MS techniques as required within the timeline.
- Review documents generated on stability analysis, validations, method transfers, and calibrations.
- Execute validation protocols and routine analysis.
- Prepare validation and stability protocols and reports.
- Prepare SOPs, EOPs, and IOPs and provide training whenever required.
- Prepare draft investigation reports for deviations, incidents, OOC, and OOS.
- Ensure the entire instrument for intended use meets the 21 CFR part 11 compliance.
- Oversee the quality aspects of stability operations and ensure 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 with ICP-MS/ ICP-OES/ AAS and FES and other wet analysis instrumentation.
- Should be familiar with cGMP and ICH guidelines.
- Good knowledge of US/EU pharmacopoeias and its recent updates.
- Should be thorough with stability operations.
- Should have good hands-on experience in execution of stability testing in line with ICH guidelines and strict adherence to 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
Link to Original Notification to apply
Keywords: Senior Executive, Job Posting, Syngene, Bangalore, Analytical Chemistry, ICP-MS, ICP-OES, Safety, Quality Control, cGMP, ICH Guidelines. MPharma Job Syngene: Senior Executive Role! Apply Now! Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
