Quality Control - Stability (formulation) Job in Syngene International Limited

JOB DESCRIPTION

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

About Syngene
Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

Job Purpose: This role involves stability sample testing using laboratory instruments like High Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Ultraviolet (UV) spectrophotometer, etc. Particulate Matter Analysis. Method Validation and Method Transfer work.

Key Responsibilities:
Ensure proper planning and executions of laboratory analysis, method development, method validation, method transfer work within window so as ensure first pass analysis avoiding human errors.
Ensure that the data generated is accurate, scientifically valid and compliant to the procedures and maintain the lab work as per Current Good Manufacturing Practice standards (cGMP) standards.
To ensure immediate escalation of issue not in conformity with the applicable procedures/policies etc.
Responsible for closure of apparent error, incident, deviations, Out of Specification (OOS), Out of Trend (OOT), and Out of Calibration (OOC) related investigation, and ensuring that they are handled and closed in scientific, logical, and compliant way in timely manner. Appropriate Root cause defined, Corrective and Preventive Actions (CAPA) identified and executed. Change Control Form (CCF) evaluated executed and closed in timely manner. Extensions if required taken in timely manner. Complete ownership of initiated quality record.
After identification, quality record (apparent error, incident, deviation, OOC) need to be opened within 24 hours, assessment and write-up need to be submitted through tracker within 7 days or at an earliest per the issue in hand.
In case of OOS, OOT regulatory timelines need to be followed.
Competency matrix score need to be improved and two new techniques need to learned and qualified.
Ensuring compliances to EHS policies, cGMP policies, data integrity policies, business policies, finance policies and IT policies as per requirements.
Adherence to Good Laboratory Practice.
Responsible for Maintenance and Calibration of assigned Measuring and Testing Equipment / Instrument in Quality Control (QC) in coordination with Maintenance department
Attend mandatory trainings as and when conducted.
Ensure trusting, collaborative and ethical work environment.
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
Attend training on environment, health, and safety (EHS) measures imparted company

Educational Qualification:
M. Sc

Technical/functional Skills:
Requires good experience in analyzing sample using HPLC, GC, UV Spectrophotometer, Polarimeter, KF, auto titrator
Attend training on environment, health, and safety (EHS) measures imparted company

Experience:
Should have 3-6 years of experience in stability sample testing
Experience on LCMS or GCMS will be added advantage

Behavioral Skills:
Good communication and e-mail writing skills
Fair interpersonal skills.
Good Team player
Able to work follow instructions and perform the tasks under the supervision of the Team leader

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.