QA Officer

The QA Officer is responsible for ensuring compliance across daily operations and services requiring Quality Assurance (QA) involvement. To primarily provide QA support for production activities, but also to Warehousing and Quality Control departments, and ensure that all stages of Good Manufacturing Practice (GMP) are in full compliance with the principles of Good Practice (GxP) guidelines and other regulatory requirements.  The QA Officer will provide QA support in deposition decisions, and the release of intermediate and finished products through the review of batch documentation, Certificates of Analysis (CofA’s) and laboratory testing results. To support production Team leaders in achieving GMP compliance excellence, and promote Quality Culture within the business

 

Key Responsibilities

 To review Manufacturing batch records production documents to ensure all tasks performed are in keeping with GMP.

• To ensure production anomalies are reported to QA Management via Deviation documentation or a ‘Quality Incident Report’.

• To co-ordinate the prompt resolution and/or closure of change control’s, deviations and QIR’s raised within your area of responsibility.

• To review Quality Control (QC) test data to ensure accurate recording and trend analysis.

• Ensure all in-house manufactured, and third party produced, finished products and associated documentation are retained promptly and accurately, and remain in an inspection ready state.

• Review and release of non-licensed products via the ERP System.

• Remain up to date with actions and SOP’s via both electronic and paper-based QMS systems

• To co-ordinate customer complaints investigation, in conjunction with the QC and Customer Service departments and provide reports and recommendations as necessary.

• Support the internal audit schedule of production and warehouse facilities to verify and monitor the applied principles of GxP.

• To provide advice, guidance, and training where required to employees relating to QA to ensure a full and thorough understanding of GMP on site. • To own and implement improvement projects across the site that increase Quality compliance and Complete Product Quality reviews for the selected time period

• To work closely with all staff on site and especially production staff to ensure a good quality culture and openness 

• To provide support to the daily operation staff regarding quality decisions

• To work closely and liaise with QP’s and Quality management to ensure any information regarding quality and production are completed in a timely manner  

 

Person Specification 

Education / Qualifications 

• Degree educated or above in a Science subject 

 

Skills and Experience 

Essential

• Experience of a QA/QC role in either food or Healthcare

• Knowledge and practical experience of GMP

• Good knowledge of Quality Control Laboratory techniques, necessary for review.

• Numerical, analytical and investigative skills

• Strong interpersonal and communication skills

• Ability to work accurately, with attention to detail

• Ability to prioritise and deal effectively with a varied workload 

 

Desirable 

• 3+ years experience within a GMP environment 

• Ability to form strong working relationships with stakeholders at all levels across the organisation 

 

Behaviours

• Team player with strong communication skills

• Flexible approach to work and tasks 

• Approachable and friendly

• Confidence to challenge results and performance

• Pro-active