Title of Post: / Senior QA Officer
Pay Range: / B
Department/Directorate: / Quality Assurance
Accountable to: / Senior Qualified Person
Main Job Purpose
Review all batch records to establish that products are in compliance with licence, specifications and GMP, and FTR lead times on behalf of the QP releasing product.
To operate BPL’s Quality System and assist the Qualified Persons (QP) in all aspects relating to batch review. To ensure records are thoroughly reviewed by Production and Technical and that any issues have been dealt with.
To ensure a secure plasma system operates, including notifications and traceability and
to act as the technical specialist for Plasma received by BPL fractionation site.
Ensure compliance guidelines and directives relevant to the manufacture of medicinal products derived from human blood or plasma as detailed in EU GMP Vol. 4 Annex 14 Addendum and maintain compliance with PMF.
Organisational Structure
Key Duties and Responsibilities
To coordinate level 2 Out of Specification investigations as required in line with the site SOP and MHRA/FDA guidelines.
Collate and critically review batch-manufacturing records for compliance with licence, specifications and GMP.
Request corrective and preventive actions (CAPA) as a result of critical record review. Assess CAPA for appropriateness and encourage future compliance.
Assessment of process intermediates and, where required, release to the next stage of processing.
Store batch data by the use of spreadsheets and databases.
Co-ordinate and maintain the databases for controlled changes, plasma, product and manufacturing incidents, customer complaints and adverse drug events.
Maintain the security of BPRs and other documents.
Ensure concerns regarding product safety and quality are drawn to the attention of colleagues and appropriate staff including QA management.
To undertake QA work related to objectives as directed by the QA management.
Prioritise incoming work so that batch progress is maintained to required lead times.
Identify upcoming rate limiting steps in review so that delays are minimised.
Arrange time slots to witness processes and assist in quality improvement measures.
Where possible, maintain a system for prioritising work to ensure effective work flow.
Plan for absences and hand over work to peers in an orderly fashion.
Routine duties tend to be dealt with in a reactive manner.
To ensure a secure plasma system operates, including notifications and traceability.
Key stakeholders/Participants during Regulatory and Customer audits,
Acceptance and Review
Accepted
Manager...... Print Name……………………...... Date......Jobholder...... Print Name……………………...... Date......
H:\D05\DATA\PERS\Recruitment\Job Descriptions (JD)\Technical\QA\QA Specialist - Jan 2015.doc
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