Job description
We are looking for a motivated and experienced Validation Specialist in a healthcare manufacturing environment. The ideal candidate will be responsible for the development, implementation, and execution of validation activities for small-scale equipment and related software, ensuring compliance with cGMP, user, and regulatory requirements.
Key Responsibilities:
* Develop, implement, and execute User Requirement Specifications (URS), System Impact Assessments (SIA), and validation activities including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Traceability Matrix (TM).
* Conduct validation studies for cGMP-critical process systems, demonstrating compliance with industry standards and regulatory requirements.
* Perform hands-on qualification of systems, interpreting standards to fit specific cases in accordance with cGMP, cGLP.
* Maintain the qualified status of systems, ensuring ongoing compliance with cGMP regulations.
* Support projects and cGMP regulatory standards.
* Stay updated on emerging validation regulations and testing practices to meet or exceed cGMP requirements.
* Provide technical assistance regarding current US FDA and EU validation requirements.
* Manage validation documentation through approval and implementation processes.
* Assess changes to determine their impact on qualified status and validation documentation.
Qualifications:
* 2 to 6 years of experience in a healthcare manufacturing environment, with a focus on the qualification of small-scale equipment and related software.
* Strong knowledge of cGMP requirements and relevant quality and compliance regulations.
* Proven ability to troubleshoot validation issues effectively.
* Familiarity with quality management systems and validation documentation processes.
* Excellent communication and teamwork skills.
What We Offer:
* Competitive salary and benefits package.
* Opportunities for professional development and career advancement.
* A collaborative and innovative work environment.
* The chance to make a meaningful impact in the healthcare industry.