Calibration and Documentation Engineer
Bangalore, KA, IN, 560099
Designation: Calibration and Documentation Engineer
Job Location: Bangalore
Department: Chemical Development – Engineering and Maintenance
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 support characterization, analytical method development, validation, and dose formulation analysis.
The role will involve conducting all work in compliance with applicable regulatory requirements and Good Laboratory Practice.
Key Responsibilities:
- Assist in the conduct of the study in compliance with the Principles of Good Laboratory Practice.
- Operating analytical equipment and ancillary equipment
- Compliance with the study plan and Standard Operating Procedures applicable to their involvement in the study.
- Recording of data with compliance to ALCOA+ principles
- Documenting and communicating and deviation to supervisor/team lead/study director
- Ensuring health and safety practices at the workplace
- Communicate with Management, QAU, Document Controller, TICO, and Archivist as per the Study Director's instructions.
- Verify the calibration and maintenance of the instrument/equipment before the start of the experiment.
Educational Qualification:
- Bachelor of Engineering (Any Specialization)
- Strong knowledge on calibration of Field instrument
- Strong Knowledge on cGMP documentation and preparation of standard operating instruction.
- Strong knowledge on handling of Master instruments.
- Experience on preparing Schedules for calibration and Execution.
- Experience on Servicing and trouble shooting field instruments.
- Experience on handling internal and External audits
- Knowledge on compliance documents and filling data sheet.
Experience:
- 3-9 years in calibration and documentation
Behavioral Skills:
- Good communication skill, both verbal and written
- High level of dedication, enthusiasm, motivation, and persuasive ability in a team and cross-functional environment.
- Ability to work successfully in a dynamic, ambiguous environment.
- Ability to meet tight deadlines and prioritize workloads.
- Ability to develop new ideas and creative solutions.
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.