Senior Executive

Designation: Analytical Analyst - ICP-MS/ ICP-OES
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: To oversee method transfer, validation activities related to elemental assay and trace analysis, characterization of elemental impurities in trace and assay levels

Key Responsibilities:
Planning of day to day activities and reviewing of documents.
To execute stability analysis, validations and method transfers on Flame emission spectrometry (FES), Atomic Absorption Spectrophotometer (AAS), Inductively coupled plasma Optical Emission Spectroscopic (ICP-OES) and Inductively coupled plasma mass spectrometry (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 Standard Operating Procedures (SOPs), Emergency Operating Procedures (EOPs) and IOPs and provide training whenever required.
To prepare draft investigation report for the deviations, Incidents, Out of Control (OOC), and Out of Specification (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 Laboratory information management system LIMS
Attend training on environment, health, and safety (EHS) measures imparted company
Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

Educational Qualification:
M. Pharm / M. Sc

Technical/functional 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.

Experience:
3-5 years of relevant experience in Quality Control department/Analytical Development Lab

Behavioral Skills:
Good communication, technical report writing skills and E- Mail etiquette.
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 disability