ARx Recruitment Services

Are you a seasoned Pharmaceutical Qualified Person (QP) ready to lead and inspire in the pharmaceutical specials manufacturing sector? ARx Recruitment Solutions is thrilled to partner with a prominent pharmaceutical specials manufacturer in Essex, and we're seeking a talented Lead QP to spearhead quality assurance and regulatory compliance efforts within their dynamic team. About the Role: As the Lead QP, you will take on a pivotal role in overseeing and ensuring the quality, safety, and compliance of pharmaceutical specials manufactured at our client's facility in Essex. You will provide strategic leadership, guidance, and expertise to uphold regulatory standards, drive operational excellence, and foster a culture of quality throughout the organization. Why Join Us: Leadership Opportunity: Lead a dedicated team of professionals and drive quality assurance initiatives within a specialized pharmaceutical manufacturing environment. Innovative Setting: Work within a state-of-the-art facility equipped with advanced technologies and resources dedicated to producing high-quality pharmaceutical specials. Impactful Work: Your leadership as a QP will directly impact the production of tailored pharmaceutical solutions, positively influencing patient care and outcomes. Professional Growth: Join a company committed to investing in your professional development and offering opportunities for career advancement and skill enhancement. Requirements: Qualified Person (QP) status in accordance with MHRA regulations, with extensive experience in pharmaceutical manufacturing and specials manufacturing expertise. Comprehensive knowledge of Good Manufacturing Practices (GMP) and other relevant regulatory requirements specific to pharmaceutical specials manufacturing. Proven leadership experience, with the ability to inspire, motivate, and mentor teams to achieve quality and compliance objectives. Strong analytical skills, attention to detail, and problem-solving abilities. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders. If you're ready to lead with excellence and make a significant impact in pharmaceutical specials manufacturing in Essex, we want to hear from you! Don't miss this opportunity to join a dynamic team dedicated to delivering innovative pharmaceutical solutions and improving patient lives. Apply now and take the next step in your leadership journey!

What do you go to work for? Passion, Meaning, Purposeful Progression? We are fortunate enough to be representing a client that is pioneering global responsible pharmaceutical products and revolutionising the GMP pharmaceutical environment. Whilst most life science companies are 'restructuring' and reducing headcount, this innovative organisation is growing and expanding, including the creation of new facilities. As part of this growth, our client needs a Qualified Person (QP) to help support their Quality Assurance team as the business grows. Working as part of a 4 person team of QPs, this individual will be responsible for batch release, QMS support and more. A QP role with real meaning, real (global) impact, and with massive expansion plans. Are you looking to make a difference? Do you want to get excited about going to work again? Apply now!

We have the priviledge of bringing to market a career altering opportunity with a leading Medical Device organisation based in the heart of London. If you are an experienced QA Manager looking for a role where you can make a real impact, this opportunity would be the ideal fit for you. How can you help the client? Complete design, implementation and maintenance of a brand new QMS (Quality Management System) in line with relevant ISO / IEC requirements and other regulations Develop SOPs, policies, procedures, documents etc for all quality related processes Keep in close contacts with your team (Scientists, Analysts etc) to perform RCA (Root Cause Analysis) investigations for non-conformances in a timely manner Prepare and manage accreditation submissionns, which ensures ongoing accreditation compliance Continual maintenance of up to date lab records and adherence with the quality management system Make sure all data / reports are checked and backed up in line with the QMS and in compliance with GDPR Work in conjuncture with external teams and regulatory bodies to help in the advancement of the product Add input into the creation, maintenance, improvement and implementation of SOPs Troubleshoot technical issues Continuous improvement projects Among other responsibilities of working within a small but fast paced team. What experience do they need to support them? A relevant Degree (Life Sciences) or experience within a relevant field (technical / scientific role) Experience in developing and rolling out a QMS ISO/IEC 17025 Implementation Experience in Leadership / training staff within a Quality GLP environment Self starter - with the ability to sent own tasks and goals and drive themselves forward This role is a phenomenal opportunity for someone to put their own stamp on a phenomenal new organisation and make a real impact within their field. This would suit someone confident in their abilities, driven to make an impact and available to build a team and QMS around them that will last the long haul. Do you think you could help? APPLY NOW - for more information and a confidential conversation!

CMDO is Seeking to Appoint a Qualified Person. The Organisation is Engaged in Developing and Manufacturing New Medicines and Novel Formulations, Including a Wide Range of Oral Solid and Liquid Dosage Forms, Sterilised and Aseptically Filled Products, as well as Manufacturing and QP Certification of a Range of Phase I/II Clinical Trials for the UK and EU Markets, ROLE Perform the Legal Duties of a Qualified Person (QP) on the MIA(IMP) as Specified under EC Directive 2001/20/EC and Human Medicines Regulations 2012 Ensure Compliance with the Requirements of Eudralex Volume 4, Part 1, Annexes 13 and 16 Undertake QP Batch Certification and Release Functions within Departments Named on the Relevant Site Manufacturers Authorisation (IMP) Responsible for All QP Activities and Associated Resource Planning, Training, Development and Management Ensuring the Completeness and Effectiveness of the of Pharmaceutical Quality Management System and Pharmaceutical Quality Control Service as per the requirements for the Qualified Person, Described in Human Medicines Regulations 2012 and EudraLex Volume 4, Part 1, Annex 13 and Annex 16. REQUIRED Masters Degree in Pharmacy, Biochemistry, Chemistry, or Life Sciences Extensive Specialist Knowledge and Experience of Batch Certification/Release of Sterile Injectable Manufacture, Manufacture of Specials (Unlicensed) Medicinal Products, Investigational Medicinal Products for Clinical Trials and Radiopharmaceuticals Eligibility to Function as an EU QP for Investigational Medicinal Products under Statutory Instrument 2004:1031 Eligibility to Function as an EU QP Under the Permanent Provisions for Medicinal Products Under Statutory Instrument 2012:1916 Extensive Experience in GMP Validation of Pharmaceutical Facilities, Utilities, Equipment, Processes and Analytical Methods Managerial Experience in a Pharmaceutical Organisation and a Track Record of Compliance at Regulatory Inspections Experience of Research and Supply of IMP Medicines for Clinical Trials Expert Knowledge of GCP, GMDP, Quality Systems and Pharmaceutical Analysis Expert Knowledge of Pharmaceutical Microbiology and Quality Control Expert Practical Knowledge of GCP, GMDP, QA and All Current Relevant Regulations Expert Technical Knowledge of Pharmaceutical Sterile and Non -Sterile Manufacturing Demonstrable Ability to Risk Assess, Perform Root Cause Analysis and Resolve Deviations and Out of Specification Results and Develop Suitable CAPAs Demonstratable Ability to Ensure Quality through Set-Up, Manufacturing and Release of IMPs under a MAIMP to Comply Fully with the Requirements of GMP and GCP REMUNERATION 90K, Subject to Qualifications and Experience

What does 'family business' mean to you? For some, it's code for small, for others it is a collaborative and friendly space. The truth - it's usually both. Family, small to midsized pharmaceutical companies look after their staff. You become part of their community, their culture, and the way they do things. In our experience, staff at family run SMEs experience longer levels of employment than at large global corporations, and are often compensated well over time for their rewards. Which is why, I am delighted to be representing a leading (family run) pharmaceutical manufacturing organisation based near Watford in the UK. This amazing company are going through a great transformation that should ensure the company's future for generations to come, and as part of that they are looking for reliable, professional and hard working Regulatory Affairs professionals. As part of this expansion, our client is looking for someone with 5+ years experience in Pharmaceutical Regulatory Affairs (ideally in a similar style of company, but they are open to people from all different pharmaceutical organisations). You need to have a hard working attitude, good attention to detail, and you need to be able to work well with your team. Your experience in eCTD manager and document management tools will be valued, and you will need knowledge of global Regulatory requirements and guidelines (MHRA, EMA and ICH). This is a site based role near Watford (5 days per week) and would suit someone looking for a company they can grow with, and build with, and that will give them huge career tragectory in a culture that is supportive and dynamic. Interested? Apply Now!