Syngene International Ltd. is looking for competent canChedidates for the position of Senior Executive – Analytical Development – Early Face GMP.
Incorporated in the year 1994, Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompass all across the discovery chain: early-stage discovery, process development, cGMP manufacturing, and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built-up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & amp; regulatory agencies and have received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP, and AAALAC.
Over the past 16 years, Syngene has successfully partnered with leading pharmaceutical companies, large biotech companies, crop protection companies, and cosmetics companies. Syngene together with Bristol-Myers Squibb has set up a dedicated research facility in Bangalore to help advance Bristol-Myers Squibb’s work in discovery and early drug development.
To advance its programs and expand its capabilities, Syngene is looking to recruit outstanding scientific talents.
So come and join us in our journey of scientific innovation.
For further details, please visit www.syngeneintl.com.
Title: Senior Executive
Department: Analytical Development – Early Phase GMP
Qualification: M.Sc. Chemistry / Analytical Chemistry
Experience: 4-9 years
- Should have Quality Control background.
- Should have knowledge of Analytical Techniques
- Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
- Good speaking-listening-writing skills, attention to detail, proactive self-starter.
- 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.
- Should be strong in Data Integrity.
- Should able to work in team and flexible for working in shifts.
- Should be a focused employee.
This role involves the analysis of Drug Substance/ Drug Product.
- Responsible for performing the physicochemical and instrumental analysis and investigations of samples (Drug Substance, Drug Product, Intermediate, Excipient & Inactive) received at Early phase GMP (Analytical Department). Preparation of protocols, ODS, and Annexure as per client requirement.
- Responsible for handling stability for multiple Client projects.
- Preparing stability summary reports and review of final documents.
- Actively participate in Client Audits and regulatory Audits. Ensure to follow cGMP and GDP.
- Deliver analytical results within the established windows and as per applicable guidelines.
- Responsible for performing Validation activities and method transfers for multiple Client projects.
- Preparing the Calculation excel sheets, certificate of Analysis for standards and impurities, and Reports for Analytical Method Validation and Analytical Method Transfer.
- Responsible for Performing Qualification and Calibration of assigned Instruments and Equipments.
- Preparation of Instrument URS, DQ, and IOP.
- Preparing the Standard Operating Procedure.
- Responsible for timely intimation/ investigation of any events, deviations to the Dept. Head, QA function and supporting the related investigations to the clients and its effective timely closure.
- Responsible for Timely deliverables of projects.
- Compliance & implementation of quality systems.
- Ensure optimal utilization of Work hours & prioritization of activities to meet departmental commitments.
- Flexibility to work in any project/team as per the requirement.
- Responsible for the activities assigned within the team.
- Escalation of issues / non-conformity with applicable procedures/policies.
- 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.