Seeking a Validation Associate with experience in the pharmaceutical space.
This is a 6-month contract with a view to go permanent, located in the Western Suburbs of Melbourne.
About the role:The primary focus of this role will be drafting cleaning and process validation protocols. Furthermore, protocols for equipment qualifications (IQ, OQ, PQ) will also be required, ensuring compliance with the Quality Management System (QMS) and regulatory standards.
Other responsibilities will include maintaining validation documentation, supporting audits, collaborating with stakeholders, and identifying process improvements. Ensuring up-to-date training certifications is also essential.
Responsibilities:Draft validation protocols for cleaning and process validationsDraft Equipment qualification protocols (IQ, OQ, PQ)Identify critical control points (CCP) and perform risk assessmentsDraft protocols for temperature mapping of warehouse, stability chambers, ovens, and fridgesBuild and maintain strong collaborative relationships with key stakeholdersParticipate in internal (e.g., Quality Compliance, Safety and departmental) and external (e.g., TGA, FDA) audits, as requestedActively participate in problem-solving and identify opportunities for improvement to optimize validation activitiesEnsure all training certification requirements are up to dateQualifications:To be successful in this position, you will have tertiary qualifications in science and/or engineering with previous relevant experience within a pharmaceutical manufacturing environment.
Application Process:If you think this could be the role for you, please apply now! Send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted/not processed).
For any questions, please contact Cathy or Deborah on 9040 1630.
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