GMP Compliance Officer

7 days ago


Fatih, Istanbul, Turkey Novartis Farmacéutica Full time
Role Summary

The Quality Operations Specialist plays a key role in ensuring the quality strategy is implemented and driving continuous improvement in product and process quality.

This involves managing Quality aspects and projects within area of responsibility, ensuring overall GxP conformity and Compliance with the Novartis Quality Management Systems.

The successful candidate will review and approve production electronic batch records and QC related documentation to ensure adherence to Novartis policies, SOPs, and cGMP requirements.

Main Responsibilities
  • Shopfloor Activities:
  • Conduct routine Quality Operations related activities at shopfloor including, but not limited to, observations and walkthroughs.
  • Perform training of events on shopfloor for PU and QC laboratories as well as other support areas.
  • Review Activities:
  • Review and approve production electronic batch records (EBRs), and/or QC related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements.
  • Interface closely with PU and QC to assist with batch record/QC data review, release, and compliance issue resolution.
  • Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction.
Requirements

Desirable Skills and Qualifications:

  • Min. 2 years of experience in pharmaceuticals is preferred.
  • Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations.
  • Excellent oral and written communication skills are required.
  • Demonstrate leadership ability and excellent interpersonal skills.
  • Ability to work as part of a team.
  • Strives for simplicity and clarity.
  • SAP, 1QEM, MES, LIMS knowledge is preferred.
Why Join Our Team?

We're passionate about delivering high-quality products and services that make a real difference in people's lives.

We're committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Benefits and Rewards

We offer a comprehensive package of benefits and rewards to support your career development and personal growth.

Read our handbook to learn about all the ways we'll help you succeed.



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