Validation/ Qualification Program (IQ/OQ/PQ) Lead

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Company: Katalyst HealthCares and Life Sciences

Location: Richmond, VA 23223

Description:

Responsibilities:
  • Established to ensure that all finished product is manufactured, packaged and labeled as intended, including conformance to applicable legal and regulatory requirements. Product requirements also relate to conformance to raw material, component, intermediate material, in-process requirement, and finished product attributes.
  • Oversee the validation of manufacturing equipment, systems, and processes to ensure they meet regulatory requirements and are operating according to specifications.
  • Lead the qualification of new equipment, ensuring that it is installed and operates within expected parameters. This includes Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Ensure that the manufacturing processes are validated according to regulatory guidelines, such as FDA 21 CFR Part 820, ISO 13485, or other relevant standards. This may involve process validation (PV) and re-validation when changes to processes or equipment are made.
  • Oversee the validation of manufacturing systems, to ensure they function correctly and meet compliance requirements.
  • Develop and implement validation plans, protocols, and reports, ensuring they are comprehensive, compliant, and executed correctly.
  • ddress any deviations or non-conformances identified during manufacturing or validation activities by initiating corrective and preventive actions (CAPA) and ensuring issues are properly investigated and resolved.
  • Ensure that all validation documentation, including qualification protocols, validation reports, and SOPs, is properly maintained, reviewed, and stored in accordance with regulatory requirements.
  • Collaborate closely with the quality assurance (QA) team to ensure that manufacturing operations and validation activities align with the company's quality management systems (QMS).
  • Work with the training department to ensure that manufacturing and validation teams are properly trained in procedures, equipment handling, and regulatory compliance.
  • Lead and manage the manufacturing and validation teams, providing guidance, mentorship, and support to team members. Ensure that the teams are well-trained, motivated, and aligned with company goals.
Requirements:
  • bachelor's degree in engineering (e.g., Mechanical, Chemical, Industrial), Manufacturing, Life Sciences, or a related field.
  • 5-10 years of Quality / relevant process experience in regulatory environment
  • Several years of experience in manufacturing operations and validation within regulated industries such as pharmaceuticals, medical devices, or food manufacturing.
  • 3-8 years of people leadership
  • bility to lead and manage an onshore and offshore team
  • Strong communication skills to interact with cross-functional teams, senior management, and external auditors or regulators.
  • End to end process understanding.

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