Job
Description
OLIGONUCLEOTIDE MANUFACTURING- SR. EXECUTIVE /EXECUTIVE
Designation: Senior Executive/ Executive - Production
Job Location: Bangalore
Department: Chemical Development (Production)
Experience: 1-5 years post qualification
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:
Ensuring manufacturing operations are carried out in compliance with current Good Manufacturing Practices, Good Documentation Practices and Data Integrity policy
Responsibilities:
- Monitoring and Maintaining of all Production related documents.
- Review of the executed batch manufacturing record, packing dispatch record and equipment cleaning checklist.
- Maintaining Training Record of all the production personnel's.
- Ensuring availability of BMR/PDR prior to initiation of batch.
- Coordination and preparedness for audit/visits
- Coordinating with maintenance for external calibration of weighing balances
- Initiation of change control and documents related to validation batches.
- Discussion with inter department personnel pertaining to deviations, BMR etc
- Ensuring online documentation during batch execution.
- Ensure quality and regulatory compliance are being followed inside the plant
- Ensuring attendance of employees for all training sessions assigned by the training
- Online reviewing of batch records and production related documents.
- Ensure calibration of instruments like pH meter and weighing balance in production is being done
- Documentation capabilities like writing, preparing reports and records for manufacturing
- Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety
- Attend training on environment, health, and safety (EHS) measures imparted company
Educational Qualification:
Bachelors / Masters in biotechnology or organic chemistry
Technical/Functional Skills:
- Experience in Downstream/Upstream Manufacturing/R&D
- Software: Unicorn
- Experience in Peptide manufacturing
- Computer Applications: - MS-Office, MS Word.
- AKTA process