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LIMS Documentation Specialist - e-stone
1-2 years
Vadodara
1 vacancy
LIMS Documentation Specialist - e-stone
e-Stone Information Technology
posted 4mon ago
Job Role Insights
Flexible timing
Key skills for the job
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.
Employment Type: Full Time, Permanent
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based on 10 employees
Flexible timing
Monday to Friday
No travel
Day Shift
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