Technical Operations Officer

5 days ago

Grangemouth, Falkirk, United Kingdom Piramal Pharma Solutions Full time £45,000 - £55,000 per year

The
Technical Operations Officer
plays a critical role in supporting manufacturing operations by ensuring the accuracy and compliance of executed documentation, driving timely investigations, and closing out CAPAs following manufacturing campaigns. This role is essential in maintaining operational efficiency and ensuring client expectations, quality standards, and project timelines are consistently met.

Key Responsibilities:

Documentation Review:

  • Review executed PI sheets and batch records for accuracy, completeness, and compliance with GMP and internal standards.
  • Liaise with QA to address and resolve any queries or clarifications raised internally or by the client.

Manufacturing Support:

  • Collaborate with Senior Technical Operations Officers to implement actions resulting from change controls.
  • Work with Document Control to ensure PI sheets are issued in a timely manner ahead of manufacturing start dates.
  • Coordinate with Shift Team Leaders to ensure all required labels for manufacturing are printed and available.
  • Review and update PI sheets related to cleaning procedures and buffer preparation.

Deviation & CAPA Management:

  • Support and contribute to investigations related to process deviations.
  • Assist in the timely closure of CAPAs to ensure compliance and continuous improvement.

Reporting & Data Management:

  • Compile data for end-of-campaign reports to support process evaluation and client reporting.
  • Update and maintain SOPs (Standard Operating Procedures), OIs (Operating Instructions), and PI sheets as needed.

Project & Operational Support:

  • Provide hands-on assistance during FAT/SAT activities (Factory/ Site Acceptance Testing).
  • Ensure appropriate training materials and operational documentation are developed and readily available to enhance capability and efficiency.
  • Support the Senior Technical Operations Officer with project-specific tasks and continuous improvement initiatives.

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