Asst.Manager/Dy.Manager – CQA & CQC API(Compliance & Investigations)

From 9 to 14 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

Technical skills (Essential):

  • Hands on experience on all major QC instruments and softwares
  • Must have good exposure in calibration of all major QC instruments
  • Ability to review hard copy / soft copy raw data in QC instruments and identifying the gaps with remediation
  • Exposure to different QC instrument related softwares like Empower / Lab solutions / Tiamo / spectrum / Master sizer etc. is essential.
  • To provide training to team members.
  • Review of electronic data, audit trails in all QC / Microbiology applications.
  • Review of QMS documents like laboratory incidents / deviations/ change control / OOS /OOT, Abnormal trends /calibration failures / communication failures and further impact assessments.
  • Good communication and drafting skills for writing the investigation reports / trend reports / Comprehensive assessment of QMS elements and identifying root causes for repeated incidents / deviations / failures.
  • Review of change controls and to assess the impact
  • Good knowledge and experience in handling of QC instrument / applications related Qualifications, validations, Computerized system validations is essential.

Technical skills (Desired):

  • Experience in ERP / LIMS / SAP / QMS applications etc.

Role:Quality Manager / Supervisor

Salary: Not Disclosed by Recruiter

Industry:Pharmaceutical & Life Sciences

Functional Area:Quality Assurance

Role Category:Business Process Quality

Employment Type:Full Time, Permanent

Education

PG:MS/M.Sc(Science) in Organic Chemistry, Bio-Chemistry, Biology, Microbiology, Chemistry

Company Profile

Hetero Drugs Limited

M/s. Hetero Drugs Ltd is one of the Largest Pharmaceutical Company in India.
Company Info
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Contact Company:Hetero Drugs Limited

Address:7-2-A2, Hetero Corporate, Industrial Estate, Sanath Nagar, Hyderabad, Telangana, India.

Reference Id:CQA, CQC API

Copyright © 2017 Hetero. All rights reserved.
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