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Regulatory Compliance Expert for Pharmaceutical and Biotech Industries
1 month ago
At ProductLife Group, we're seeking a seasoned Compliance Consultant to join our team in supporting our clients across the Pharma, Biotech, and Medical Device sectors.
The ideal candidate will possess extensive knowledge of validation and compliance procedures within these industries, with experience in executing system validations from IT to laboratory equipment and pharmaceutical production. Strong understanding of regulatory requirements such as GAMP and V-Model is essential.
We offer a competitive salary of $85,000 - $110,000 per annum, commensurate with experience. The role provides opportunities for growth and professional development, with increasing responsibility over time.
Key responsibilities include:
- Validating Computer Systems/Software Validation Procedures to ensure current regulatory compliance
- Identifying and mitigating risks
- Preparing and executing validation protocols and reports
- Providing IT support and assessment for quality deviations
- Recommending and managing corrective and preventive actions (CAPAs) to improve IT compliance
- Authoring SOPs and Work Instructions for IT systems
A bachelor's degree or higher is required, along with a minimum of 3-5 years of experience in the Pharmaceutical, Biotech, or Medical Device Industries, including test and validation expertise. Excellent English communication skills, both written and verbal, are essential for this role.
