- To ensure that a quality management system is implemented and maintained and appropriate to the activities at the Company inclusive of the EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C343/01) and EudraLex – Volume 4 – Good Manufacturing Practice (GMP) guidelines.
- Providing compliance support and spreading the quality culture throughout the company.
- Maintain processes (GMP documentation lifecycle, Change Control, Deviation, CAPA, self-inspections, Complaints, GMP document control and training) needed for successful site compliance to the PQS.
- Participating in reviews and suggesting improvements delving into areas of continuous growth.
- Responsible for updating & maintaining QMS related trackers.
- Ensure that the company operates in compliance with the authorised activities on the WDA and MIA licenses.
- Ensure that own premises and other contracted storage premises uphold necessary standards of GDP and GMP.
- Ensure quality, safety, integrity and security of legal categories of medicinal products named on the Marketing Authorisation and Controlled Drug Licence.
- Ensure procedure for the retention of documentation with procedures comprehensively written and understood by applicable staff.
- Ensure the appropriate storage of GxP documentation. Act as the primary company archivist. Ensure appropriate process in place for the recall of documents when requested.
- Ensure effectiveness of procedure for identification and documented reporting of product quality complaints, product recalls and handling of suspected falsified medicines.
- Support the collation and review of product quality documentation and technical data in order to check that products remain safe, compliant and of a high standard for supply.
- Proven Quality Assurance experience in the pharmaceutical industry, with a solid foundation in QA principles.
- Strong analytical skills and keen attention to detail to identify and address potential quality issues.
- Proficient writing skills, using appropriate software tools to develop and edit documents, procedures, and reports, contributing to comprehensive documentation and compliance.
- Understand the role of the MHRA (and other competent authorities) in the licensing of medicines, the risk-based inspection process, the role of the enforcement group, the Inspection Action (IAG) and resulting actions that can be taken due to non-compliance.
- Good understanding of GMP / GDP.
- Excellent attention to detail.
- Effective time management.
- Self-motivated & highly target driven.
-
Chief Quality Officer
2 days ago
Walker Cole International London Area, United KingdomWalker Cole International is supporting one of its clients in their search for a Chief Quality Officer. The business have a diverse portfolio of established and pipeline assets and are currently undergoing growth due to acquisitions. · As the Chief Quality Officer, you will drive ...
-
Route23 Recruitment London Area, United KingdomRecruitment Consultant · Salary: £26,000-£30,000 + Up to 30% Commission + Other Rewards/Benefits · Central London/ Hybrid · I am currently looking for ambitious, financially driven individuals who would relish the opportunity in joining one of the largest recruitment establishm ...
-
Executive Assistant
2 days ago
ISE Partners London Area, United KingdomThis Mayfair based private equity firm requires an experienced Team EA with a minimum of 3-5 years investment sector experience in a similar role. You will be joining a dynamic office where as the senior Team EA you will be in charge of organising their constantly changing diarie ...
-
Quality Manager
3 days ago
The People Co. London Area, United KingdomQuality Manager (Co-Package Management) · London / Hybrid – Frequent travel · £40,000 - £50,000 plus package · Ensure product safety, efficiency, quality and compliance of Co-Packages for this favourite, brand leading global business. · The Company. · The business has grown from ...
-
Support Specialist
1 week ago
FJN Solutions London Area, United KingdomOur client is an award winning, specialist insurance solution provider who support businesses and individuals with their commercial insurance and employee benefit solutions. They are a leading organisation with a rich history of strategic acquisitions which has allowed them to gr ...
-
Facilities Assistant
3 days ago
Gatehouse Bank plc London Area, United KingdomFacilities Assistant · Gatehouse Bank plc · London – Onsite · Role purpose · To provide Facilities Support for London office and all bank staff and act as Health and Safety support for all premises. · Key responsibilities · Act as Front of House for the London office, and respon ...
-
Consultancy Operations Manager
4 days ago
Ark Workplace Risk London Area, United KingdomArk Workplace Risk is a market leading provider of operational risk, compliance and safety solutions, and work with a prestigious and diverse range of over 500 clients. · We are a leading safety consulting company dedicated to providing comprehensive safety solutions to our clien ...
-
Payment Scheme Compliance Executive
1 day ago
Payments Recruitment Limited London Area, United KingdomPayment Scheme Compliance Executive (FPS & CHAPS) · Challenger Bank based in Canary Wharf · £40-50k basic + benefits & bonus · Office based until end of training & probation, then hybrid working available · Our client is a high growth challenger bank, with an office in Canary W ...
-
Facilities Manager
5 days ago
Gatehouse Bank plc London Area, United KingdomFacilities Manager & Health & Safety Officer · Gatehouse Bank plc · London – Onsite · Role purpose · To be responsible for all premises and facilities related matters for all bank offices and all aspects of Health and Safety. · Key responsibilities · Act as the primary contact wi ...
-
Executive Assistant
3 days ago
Harmonic Finance™ | Certified B Corp London Area, United KingdomExecutive Assistant | Creative Architecture Business | London · Harmonic are delighted to be working exclusively with a dynamic architecture business in their search for an Executive Assistant to join their expanding team. This is a fantastic opportunity to join a business who g ...
-
Strategic Finance Business Partner
6 days ago
Vox Network Consultants London Area, United KingdomRole Purpose · These roles provide a broad service that set policy and provides advice to support and assure all of the council's day to day activities. They gather information required by other groups to make strategic decisions and translate this into corporate policy and strat ...
-
Vetting Superintendent
1 day ago
Zodiac Maritime London Area, United KingdomZodiac Maritime is an international ship operating company providing a full range of management services for a wide and diverse fleet of commercial ships, spanning containership to tankers, bulk carriers to PCTCs, and a growing orderbook focused on dual-fuel vessels to improve ov ...
-
Senior GRC Information Security Analyst
6 days ago
Harrington Starr London Area, United KingdomExciting new greenfield role has become available with our global end user client within their central London offices. This role has arisen due to new business expansion, and offers superb opportunities to join a small, specialist team, and the successful candidate will focus on ...
-
Serious Injury Newly Qualified Solicitor
5 days ago
William James Recruitment London Area, United KingdomSpinal / Serious Injury - Newly Qualified Solicitor – London – up to £60,000 + Excellent Benefits Package – REF 627400DL · The Role · Superb opportunity to join an award-winning leading law firm that offers specialist quality legal advice. · The firm is recognised for its outstan ...
-
Product Delivery Manager – Data Products
6 days ago
Cornwallis Elt London Area, United KingdomProduct Delivery Manager – Data Products / Agile / Stakeholder Management – Contract – 8 Months - Up to £550 p.d Outside IR35 · A global media organisation is seeking a Programme Manager join their London based office on an initial contract running until the end of 2024. In this ...
-
Product Manager
2 days ago
Usurpo London Area, United KingdomACCA/CIMA Qualified · Our client, a rapidly growing accounting-tech start-up, pioneers automation and AI to alleviate manual tasks for finance teams. With a bold long-term vision, they aim to revolutionise month-end processes and enable real-time accounting. Currently comprising ...
-
Java Developer
2 days ago
Bentley Whitaker Search and Selection London Area, United KingdomJava Developer- Java, Spring Framework, Microservices, REST, API platform development, Reactive programming, Kubernetes. · Description for the Java Developer role:- Fantastic opportunity to join a very well funded award winning Fintech based in central London as a Java Developer. ...
-
Project Estimator
1 week ago
VVB Engineering London Area, United KingdomVVB are hiring for Estimators to work on various exciting projects throughout the UK. · Are you an Estimator looking for a new opportunity? Or maybe you are an ex trade Electrician or Fitter with some good knowledge of estimating techniques, looking for a change ? This may be the ...
-
Microsoft System Administrator
3 days ago
Pearson Carter London Area, United KingdomMicrosoft System Administrator - £85k + 10% bonus - Hybrid · Pearson Carter is working with one of the largest independent fund administrators, delivering a range of services and technology to private debt, hedge funds, fund of funds, private equity funds, private banks, pension ...
-
Senior Project Manager
3 days ago
Marks, part of SGS & Co London Area, United KingdomMarks is a brand design and experience agency that is uniquely constructed to enable brands to win in an age of constant change. Fuelled by our dual vantage points – embedded partners and future-forward experts – we build brand momentum to move fast, move forward, and move confid ...
Senior Quality Assurance Officer - London Area, United Kingdom - Invenia Group
Description
Role:
The Senior Quality Assurance Officer will conduct, coordinate and support quality aspects of the Company business operation, ensuring quality compliance throughout the business with focus on WDA, MIA and GMP and GDP activities.
Key Responsibilities:
Qualifications, Experience & Knowledge Required:
