Organisational Level

Position is equivalent to QA Operations Manager / QA Compliance Manager and reports to the site Quality Director

• Depending on the size/complexity of the site the incumbent may or may not have man management responsibilities.
• Incumbent will need to operate within a matrix management system to deliver their key responsibilities
• Probably fulfils the role of site Microbiologist (SME) but is not the QC Microbiology Manager

Purpose of the Role

Single person accountable for sterility assurance across site and will own/promote/define the systems listed as key responsibilities.

Key Responsibilities:

• Contamination control strategy (define/own/maintain for the site)
• EM & APS program (define/oversee/improve)
• Aseptic Comportment/Training/Oversight (Manage)
• Sterilization processes (oversee)
• Risk assessments and improvement programs (implement/manage - against current and future expectations)
• Lead major investigations into issue impacting sterility Assurance (i.e. Adverse EM trends, media fill failures)
• Review & approve any Major/Critical deviation and any change proposals with Sterile Assurance impact (lead)
• Staying up to date with best practice and sharing that knowledge (10% of time should be devoted to this)
• Act as SA SME for the above with regulators / clients (i.e. key part of major audits)
• Act as SA SME for new product introduction and for applicable capital projects (i.e. new lines/processes)
• Implementing best practice (e.g. ensuring understanding / compliance with SA related regulations & guidance – owning the transition and any risk assessments we need)
• Represent site on the Sterile Working Group (potential future team leader) actively harmonizing practices across sites in the network
• Report status of and promote Sterility Assurance within the Senior Leadership Team (lead)
• Audit other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Qualifications:

• Relevant science based degree; e.g. Microbiology, Applied Biology.
• Management qualifications (or equivalent experience).

Experience:

• Typically from a microbiology QC background, ideally within a sterile manufacturing site.
• Substantial experience working in a pharmaceutical quality function, preferably within a sterile manufacturing site.
• Has intimate knowledge of sterile processing at a supervisory/management level, ideally will have managed one or more sterile production lines.
• Experience with validation of sterile processes would be advantageous
• Involvement in capital projects (new build/refurbishment of sterile lines) would be advantageous
• Intimate knowledge of Annex 1 and similar guidance
• Leadership experience

• Own – SAL personal responsibility

  Manage – SAL owns content, someone reporting to SAL (dotted line) executes.

  Define – SAL sets expectations (in harmony with QS & SWG) & signs off on system.

  Oversee – SAL provides independent review of system to ensure its defined correctly & working correctly

  Improve – SAL spots issues and initiates corrections. System owner executes.

  Implement – SAL puts this in place either alone or with dotted line resource

  Demonstrable audit/client facing experience.

Key Skills:

• Influencing
• Curiosity
• (What we are attempting to do is make the SAL define the EM system, oversee its effectiveness, identify any weaknesses and initiate any required improvements. To make this work they probably should be a dotted line arrangement in place between the SAL and other members of staff ).