Quality Assurance Officer (Laboratory)

Location

Wimbledon, Greater London | United Kingdom

Job description

Responsible for ensuring compliance across daily operations and services requiring Quality Assurance (QA) involvement. To primarily provide QA support for laboratory (Quality Control/Stability) activities, but also to Warehousing and Production 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. To provide QA support in deposition decisions, and the release of starting materials and review laboratory testing results for intermediate and finished products. To support production Team leaders and laboratory teams in achieving GMP compliance excellence and promote Quality Culture within the business.

Key Responsibilities

• To review and approve laboratory test records for Quality Control and Stability to ensure all tasks performed are in keeping with GMP.
• To review and approve Quality Control (QC) and Stability test data to ensure accurate recording and trend analysis
• Review and release starting materials in the ERP system (SAP) (raw materials, packaging materials). Perform trending of stability data within a timely period of the stability time point completion
• Ensure that all Out of Specification (OOS) results are reported and investigated via the correct procedures
• Ensure OOS investigations are completed in a timely manner. Analyse OOS trends and lead CAPA to rectify recurring instances
• Review and approve material and product specifications
• To ensure laboratory 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.
• Ensure all in-house manufactured, and third party produced, starting material and finished products and associated documentation are retained promptly and accurately, and remain in an inspection ready state.
• Remain up to date with actions and SOP’s via both electronic and paper-based QMS systems
• Review audit trails for laboratory instrumentation (HPLC, GC-MS etc)
• 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.
• Support vendor management activities including vendor audits, QTA’s, vendor questionnaires.
• 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
• Complete Product Quality reviews for the selected time period
• To work closely with all staff on site and especially laboratory 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

Requirements

• Ideally degree educated or above in a Science subject

• Experience of a QA/QC role in either food or Healthcare
• Knowledge and practical experience of GMP& GLP
• 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

Bonus if you have

• 3+ years experience within a GMP environment
• Ability to form strong working relationships with stakeholders at all levels across the organisation

Benefits

💰 Annual bonus

🏝 25 days holiday per year PLUS Christmas shut down - whoop!

🌺 Free products and staff discounts to keep you healthy and happy

✨ Paid days off to volunteer for some awesome charities

Cycle to work scheme Free, weekly yoga class We also have regular socials plus all your standard stuff such as pensions, eye test vouchers and season ticket loans. We can tell you all about what is available to you when you start!

Job tags

Salary