CSV – Executive/ Sr. Executive

From 3 to 8 year(s) of experience
₹ 3,00,000 - 7,00,000 P.A.

Job Description

The JRs key point for CSV executive profile :

  • Proficient in dealing with data integrity concerns, as well as maintaining a regulatory level of documents and reviewing audit trails of server and standalone systems.
  • Well versed with GLP functions such as instrument installation and qualification, Computer System Validation (URS, GXP, FRS, FLRA SAT, CS, FS, VP, RTM, IQ, OQ and PQ) of computerized system, instrument calibration, preventive maintenance, and working standard qualification.
  • Led Good Laboratory Practices team and responsible for Planning, Review Calibration of QC Instruments and Qualification of Working standard as per respective Standard Operating Procedures.
  • Answerable for procurement and management of chemicals/Reagents, Columns and Reference Standards.
  • Skilled in Data Integrity as defined by 21 CFR Part 11 and the ability to maintain a regulated environment, Self-confidence, the ability to operate under pressure, and the ability to achieve expected results.
  • Resourceful in establishing productive, professional relationships with channel partners and key personnel healthcare fraternity and meeting assigned sales targets & strategic objectives.
  • Handling of Incidents, OOS & OOT investigations, Deviation, Change Control, Hypothesis study and CAPA effectiveness.
  • Rich knowledge of Empower Software (Creation of custom fields for online calculation & other administrative tasks)
  • Periodic walkthroughs and perform random audits to ensure compliance with Good manufacturing practices.
  • Adept in periodic walkthroughs and perform random audits to ensure compliance with best manufacturing practices.
  • Audits faced: USFDA, MHRA, PMDA, TGA ANVISA (Brazil), WHO, MOH (Canada).
  • Hands-on experience in all modern instrumentation such as  LCMS, GCMS, UPLC, HPLC, GC, UV, DR, KF, IR, and Polarimeter, Potentiometer and so on; as well as various other Analytical Techniques.
  • Customer Centric Professional with skills in addressing and resolving the client queries, complaints on priority in order to achieve customer satisfaction matrices.
  • Sound knowledge of common computer software like WINDOWS, MS-Office (Word, Excel), C Language & QC software (Empower, Track wise, SAP).
  • Implemented Computer system validation of computerized system as per GAMP 5.

An effective communicator with relationship management skills with the capability to relate to people at any level of business and management.



Key Skills
Skills highlighted with ‘‘ are preferred keyskills

Education

UG:B.Pharma in Any Specialization

PG:M.Pharma in Any Specialization

Company Profile

HR Services

Hr services

Company Info
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Contact Company:HR Services

Salary:

3,00,000 - 7,00,000 P.A.

Role Category:

Software Development

Role:

Technical Lead

Employment Type:

Full Time, Permanent