Executive QC Role at Sygene – Apply Now!
Syngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development, and manufacturing solutions company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills and capacity to deliver great science, robust data management and IP security, and quality manufacturing at speed, to improve time-to-market and lower the cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, as well as dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.
The Role Executive – QC for the Small Molecule Bioanalytical Laboratory is a technical role responsible for reviewing data for BA/BE studies in the laboratory. Job responsibilities include checking method development, validation and sample analysis data.
Key Responsibilities of the Role:
- Perform data check (QC) for method development, validation and study sample analysis.
- Review STPs, Protocols, validation and bioanalytical reports.
- Ensure necessary documents and records are updated and make it ready for the audits (Sponsor / Regulatory).
- To handle Change Management, initiate change request as and when required.
- Undertake daily and monthly inspections in the Bioanalytical Research Laboratory as and when required.
- Ensure all studies adhere to regulatory guidelines and expectations set by GCP/ GLP.
- Discuss QC observations with the Project Leader / Group Leader / Head, BRL for corrective actions and verify the corrective actions.
- Prepare QC observation trend analysis and discuss with management on scheduled basis.
Education and Experience:
Education: M. Pharm / B. Pharm / M.Sc. in Pharmaceutical Sciences / Analytical chemistry or other related life sciences from a reputed university.
Industry Experience: Minimum of 3 years of experience in regulated small molecule bioanalysis. Hands-on experience in small molecule regulated bioanalytical experiments.
Core competencies required for the role:
Scientific:
- Brings a creative and an innovative advantage to projects
- Is curious, eager to learn and make a difference
- Thinks scientifically and understands the problem statement in assigned programs/assays
- Publishes posters, papers and articles regularly
Technical:
- Review, reports/analyzes data punctually and communicates effectively
- ICH, FDA, EMA, ANVISA Method validation Guideline
- Troubleshoots and investigates logically (is able to defend the logic behind experimental results)
- Is able to forecast risks and make mitigation plans ahead of time
- Has good organizational, project management skills
Documentation:
- Records data as per ALCOA++ policy
- Pays attention to detail
- Displays minimal audit finding index
- Writes clearly and concisely with English skills at >B+
Keywords: Executive QC, Bioanalytical Research Lab, Syngene International Ltd, Bangalore, Job Posting, Latest Executive QC role, Executive QC Role at Sygene – Apply Now!
