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GxP Compliance Specialist -SAP Systems

GxP Compliance Specialist -SAP Systems

Streamlining Workflows

3 - 6 years

|

12 - 15 Lacs

Posted:3 days ago| Platform:

Apply

Skills Required

SAP QM SAP ERP SAP SCM Gxp Compliance Sap Manufacturing

Work Mode

Remote

Job Type

Full Time

Job Description

Role Description:

GxP Expertise:

Conduct GxP compliance assessments for SAP systems and processes.
Develop and implement GxP validation plans for SAP modules within supply chain, quality management, and manufacturing.
Ensure documentation and procedures meet GxP requirements
Prepare all the GxP Documentation and Protocols
Execute all the GxP Protocols
Validation and Compliance:
Participate in the validation of SAP systems and processes for GxP compliance.
Prepare and manage validation documentation (plans, reports, etc.).
Liaise with regulatory agencies during inspections and audits.
Stay updated on evolving GxP regulations and industry best practices.

Preferred candidate profile

Bachelor's degree in Life Sciences, Engineering, or related field.
Minimum 3 years of experience in the pharmaceutical industry.
Demonstrated expertise in SAP (S/4HANA preferred), particularly modules related to Supply Chain Management, Quality Management, and Manufacturing.
In-depth knowledge of GxP regulations (FDA, cGMP, etc.).
Strong validation and compliance expertise.
Ability to work independently and as part of a team.

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