Senior Consultant

4 weeks ago

Delhi, Delhi, India PQE Group Full time

Watson LIMS - Senior Consultant

Location : Noida, Uttar Pradesh, India (On-site with significant travel)

Experience : 5+ Years

Job Summary :

We're looking for a highly experienced and meticulous Watson LIMS - Senior Consultant to join our team. You'll be crucial in leading and executing validation activities for Laboratory Information Management Systems (LIMS), with a particular focus on Thermo Scientific Watson LIMS. If you have deep expertise in LIMS validation, a strong understanding of pharmaceutical regulatory requirements, and are available for significant domestic and international travel, we invite you to apply.

Key Responsibilities :

- LIMS Validation Leadership : Take lead responsibility for validating Laboratory Information Management Systems (LIMS), with a specific emphasis on Thermo Scientific Watson LIMS.

- Documentation & Testing : Prepare User Requirement Specifications (URS), develop and execute functional test scripts, and perform Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities.

- Regulatory Compliance : Ensure all LIMS validation processes and documentation adhere strictly to 21 CFR Part 11 compliance and other critical regulatory requirements, including GMP (Good Manufacturing Practices), GDP (Good Documentation Practices), GAMP (Good Automated Manufacturing Practice), ICH, USFDA, and MHRA.

- Risk Management : Apply sound experience in Risk Assessment and Mitigation strategies specific to the pharmaceutical domain to ensure system integrity and compliance.

- Stakeholder & Project Management : Effectively manage direct relationships with stakeholders and project team members, ensuring clear communication and alignment throughout the project lifecycle.

- Tool Utilization : Utilize digital tools such as HPALM, JIRA, and Trackwise for managing validation efforts, issues, and changes.

- Proactive & Results-Driven : Take a proactive approach to identify and resolve potential issues, demonstrating a results-driven orientation to ensure successful project outcomes.

Required Skills & Qualifications :

- At least 5+ years of experience in Thermo Scientific Watson LIMS Validation or Administration activities.

- Strong understanding of GMP, GDP, GAMP, ICH, USFDA, MHRA, and other regulatory requirements relevant to pharmaceutical systems.

- Proven experience in URS preparation, functional testing, and IQ/OQ/PQ execution.

- In-depth knowledge of 21 CFR Part 11 compliance.

- Familiarity with digital tools like HPALM, JIRA, and Trackwise.

- Sound experience in Risk Assessment and Mitigation within the pharmaceutical domain.

- Functional and Administration experience on Watson LIMS is a significant advantage.

- Excellent communication skills, both verbal and written, for engaging with diverse stakeholders.

- Ability to work effectively as a team player in a fast-paced consulting environment.

- Strong problem-solving skills to diagnose and resolve complex validation challenges.

- Full availability to travel domestically and abroad (up to 50-75%) based on project needs.

(ref:hirist.tech)

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