Experience: 1-2 Years
Location : Vadodara

Job Description:

• Collaborate with business team and other stakeholders to gather and document requirements.
• Ensure implementation of LIMS by creating applicable System Life Cycle validation deliverables as per GAMP5 and other industry standards like 21 CFR Part 11 and EU Annex 11.
• Communicate effectively with stakeholders to ensure understanding and compliance with LIMS documentation
• Ensure all LIMS documentation complies with regulatory requirements and industry standards (e.g., FDA, GMP, GLP).
• Create Testing documents (i.e. IQ, OQ, PQ etc.) to ensure all the URS and SRS requirements are tested before release.  As and when required, act as tester.
• Update documentation to reflect system upgrades, new features, and changes in workflows or regulatory guidelines.
• Organize and maintain a centralized repository for all LIMS documentation, ensuring easy access and retrieval.
• Conduct periodic reviews of LIMS to ensure accuracy and relevance.
• Provide training and support to users on how to effectively use and navigate LIMS documentation.
• Assist in the development and delivery of LIMS training programs and workshops.
• Work closely with the Quality Assurance team to ensure all documentation supports quality and compliance initiatives.
• Participate in internal and external audits to demonstrate compliance with GMP requirements.

Qualifications

• Bachelor’s degree in a relevant field (e.g., Life Sciences, Information Technology or equivalent).
• Proven experience in GMP documentation, preferably within a pharmaceutical environment.
• Strong knowledge of GMP regulations and standards.
• Experience with LIMS software and its documentation.
• Excellent written and verbal communication skills.
• Detail-oriented with strong organizational and time management skills.
• Ability to work independently and as part of a team

Preferred Qualifications:

• Familiarity with regulatory requirements from agencies such as FDA etc.
• Knowledge of LIMS operations and workflows.
• Certification in Quality Management System.

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