GxP Validation

Altimetrik

7 - 12 years

13 - 23 Lacs

pune chennai bengaluru

Posted:None| Platform:

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Skills Required

21cfr part 11 validation and compliance gxp uar in gxp systems data integrity tollgate process fda regulations computer system validation gamp5

Work Mode

Hybrid

Job Type

Full Time

Job Description

Role & responsibilities

Position Summary:

Good Manufacturing Practice (GxP)

Key Responsibilities:

Lead and support GxP compliance activities, ensuring adherence to FDA, EMA, and other regulatory requirements.
Develop, implement, and maintain quality engineering procedures, systems, and standards in line with GxP regulations.
Provide quality support for the design, development, and manufacturing of products to ensure compliance with internal quality standards and external regulatory requirements.
Lead investigations into non-conformances, deviations, and CAPAs (Corrective and Preventive Actions), ensuring timely resolution and compliance with GxP documentation requirements.
Perform risk assessments and implement risk mitigation strategies related to product quality and GxP compliance.
Conduct internal audits and collaborate with external auditors to ensure GxP compliance.
Review and approve GxP-related documents, such as batch records, validation protocols, and change control documents.
Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory Affairs, etc.) to identify and resolve quality issues and drive continuous improvement initiatives.
Provide training and guidance to team members on GxP requirements and quality-related topics.
Support validation activities (e.g., process validation, equipment qualification) to ensure GxP-compliant operations.
Assist with regulatory submissions, ensuring that GxP documentation is complete and accurate.

Qualifications:

Bachelors degree in Engineering, Life Sciences, or related field.
years of experience in quality engineering or quality assurance, with a focus on GxP compliance.
Strong knowledge of GxP regulations (FDA, EMA, ICH, etc.) and industry standards (ISO, ICH Q10, etc.).
Experience with quality systems management, CAPA, investigations, and auditing.
Familiarity with software/tools for GxP documentation and quality management systems (e.g., SAP, TrackWise, Veeva).
Strong problem-solving skills and the ability to lead cross-functional teams to resolve quality issues.
Excellent communication skills, both written and verbal.
Detail-oriented with strong organizational skills.

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