No Deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope & Responsibilities:
- Provide guidance and direction on commissioning/qualification activities.
- Assist in change control assessments and reviews.
- Conduct laboratory computer system data integrity assessments and reviews.
- Lead the setup, configuration, and deployment of the LIMS system within the QC department.
- Work closely with QC and IT teams to ensure that the LIMS meets all operational and regulatory requirements.
- Customize LIMS workflows, forms, and reports to align with specific QC processes.
- Develop and execute qualification and validation protocols for the LIMS, ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11).
- Perform system validation and testing to ensure the LIMS functions as intended.
- Document all qualification and validation activities in accordance with regulatory standards.
Qualifications:
- Bachelor's degree in a relevant field (Chemistry, Biochemistry, Engineering, or similar).
- Minimum of 3-5 years of experience in QC within a regulated industry (e.g., pharmaceuticals, biotechnology).
- Proven experience in LIMS implementation, configuration, and validation.
- Strong understanding of qualification and validation processes in a GMP/GLP environment.
- Proficiency in LIMS software (e.g., LabWare, STARLIMS, SampleManager) and laboratory automation.
- Excellent project management and organizational skills.