Private Jobs in Goa- Manager – QA- Abbott

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Abbott

Job Title

Manager QA

Location/Site:

Goa

Department/Division/ Unit

QA

Reports To

Senior Manager QA

Job Duties/ Responsibilities/ Accountabilities

  • Strong academics, preferably from Govt. Pharmacy college Knowledge of Shop Floor Activities.
  • Knowledge on Quality Management System – Exceptions, Planned Deviation, OOS and OOT in Trackwise.
  • Involved in carrying out Quality Risk Management.
  • Knowledge on Process Validation principles, Review of Protocol and compilation of reports.
  • Knowledge on Hold Time study Validation principles, Preparation of Protocol and compilation of reports.
  • Knowledge on Cleaning Validation principles, Preparation of Protocol and compilation of reports.
  • Review of Product Quality Reviews.
  • To investigate the product complaints and accountable for timely closure of site complaints.
  • Review of complaint and Exceptions trends.
  • To review the CAPA and track its implementation within the timeframe.
  • To check the effectiveness of CAPA implemented.
  • To perform validation and qualification activity and ensure that validation and qualification are performed as per VMP and protocol.
  • To review the change control and evaluate the impact assessment of change control.
  • To review qualifications/facility modification protocols.
  • To Prepare and Review SOP’s. Management of Service providers.
  • To track and update QIP status.
  • To review artwork and shade cards.
  • Handling of supplier complaints.
  • Handling of significant events.
  • Any other activities/support as instructed by the superiors as and when required.

Skill, Education, Experience

  • B. Pharm / M Pharm, 8 to 14 years of experience in Regulated market,
  • Knowledge of SAP, Track wise, preferred. Good writing skills, experience in MNC preferred.

Key Competencies Requirements

Managerial

  • Able to manage multiple activities in QMS and Shop floor.

Behavioral

  • Good communication, Co-ordination and collaboration skills.
  • Team player , collaborative ,result oriented.
  • Actively involved in problem solving and providing solutions.
  • Stability – Not many job changes

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