SYNGENE Career Opportunities: Senior Executive - Analytical Development - Early Phase GMP M.Sc., M. Pharm, B.Sc. Apply Now
Job Description:
Key Responsibilities:
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 Instrument’s and Equipment’s.
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.
Educational
Qualification: M.Sc., M. Pharm, B.Sc.
Technical/functional Skills:
Should have Quality Control background.
Should have knowledge on Analytical Techniques.
Experience: 4 – 9 Years
Behavioral Skills:
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
details, proactive self-starter.
Ability to work successfully in a dynamic, ambiguous
environment.
Ability to meet tight deadlines and priorotize
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.
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