Manchester, England, United Kingdom Hybrid / WFH Options
Factorytalk
as extensive technical training will be provided. Proven experience in leading complex MES projects from concept to deployment. Knowledge and understanding of Pharma and Biotech industry & processes. Familiarity with GMP, FDA 21 CFR Part 11, GAMP5, and other relevant regulatory requirements. Excellent problem-solving, communication, and interpersonal skills. Ability to travel as required to client sites. What We Offer: Competitive More ❯
testing, including communicating testing priorities, review and approval of OOS investigations, and test method maintenance. Oversee and own the process for review and approval of analytical data for future GMP testing of raw materials, in-process materials, and finished drug products. Act as Quality Control during inspections and conferences with FDA, Notified Body, Competent Authority, and other regulatory agencies. Proactively … and ISO compliance. Support company goals and objectives, policies, and procedures. Requirements: B.Sc. in Life Sciences, Chemistry, Chemical Engineering. Minimum 5 years related experience in the pharmaceutical industry supporting GMP testing activities - startup experience a bonus. A willingness to work hard, with a driven outlook and with a strong desire to succeed, as a scientist, as a team, and as More ❯
related function within either the pharmaceutical/healthcare or related industry Experience of aseptic operations is desirable, if possible aided by experience in aseptic compounding activities Good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide This job description reflects the present requirements of the post. It is not More ❯
User Requirement Brief (URB) and User Requirement Specification (URS) with the end customer as required by the project and interfaces with validation. Co-ordination of design reviews, safety studies, GMP reviews and constructability assessments to shape the design and planning process. Preparation of Pre-Construction Information (PCI) for accountable projects as well as client HSE requirements (e.g. F10 notification). More ❯
User Requirement Brief (URB) and User Requirement Specification (URS) with the end customer as required by the project and interfaces with validation. Co-ordination of design reviews, safety studies, GMP reviews and constructability assessments to shape the design and planning process. Preparation of Pre-Construction Information (PCI) for accountable projects as well as client HSE requirements (e.g. F10 notification). More ❯
Leighton Buzzard, Bedfordshire, South East, United Kingdom
Marken
Key responsibilities: Supporting the Head of QA & RA, QA Managers, Responsible Persons and Qualified Persons with the implementation and maintenance of the Quality Management System in accordance with the GMP and GDP guidelines and GPhC, ISO 9001 and ISO 13485 standards. Supporting the ongoing compliance with relevant standards, legal requirements, regulations and the PSDL documented policies and procedures. Promoting a … of the Quality standards required and able to promote a positive Quality culture within the company. Excellent knowledge of Word, Outlook, Excel, PowerPoint, and Teams. Good knowledge of GDP, GMP and GPhC regulations, ISO 9001 and ISO 13485 standards. More ❯
and embedded analytics for production KPIs Exposure to SAP IBP, PP/DS, or advanced scheduling tools is highly desirable Awareness of industry manufacturing standards and regulatory compliance frameworks (GMP, ISO, etc.) Stakeholder & Soft Skills Strong engagement skills with manufacturing stakeholders: Heads of Production, Plant Managers, and COOs Ability to translate complex operational processes into streamlined SAP-enabled solutions Excellent More ❯
and embedded analytics for production KPIs. Exposure to SAP IBP, PP/DS, or advanced scheduling tools is highly desirable. Awareness of industry manufacturing standards and regulatory compliance frameworks (GMP, ISO, etc.). Stakeholder & Soft Skills Strong engagement skills with manufacturing stakeholders: Heads of Production, Plant Managers, and COOs. Ability to translate complex operational processes into streamlined SAP-enabled solutions. More ❯
We're Looking For Degree in a life science field or relevant experience in quality assurance/quality control. Experience in the pharmaceutical or healthcare industry preferred. Knowledge of GMP requirements for sterile manufacturing (clean room) is desirable or general experience of working within a GMP environment. Familiarity with sterile operations or compounding is a plus. If you're passionate More ❯
working knowledge and practical experience with ISO 13485, CAPA requirements, GDP, and GMP. Key Words: Quality Assurance Engineer/Quality Systems/ISO 13485/CAPA/GDP/GMP/Quality Management System/Medical Devices/Regulatory Compliance/Internal Audits/Supplier Quality Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from More ❯
in achieving key milestones and progressing towards clinical readiness, positioning IRBM as a major player in driving innovation in the pharmaceutical and biotech fields. IRBM Group also has a GMP - certified Contract Development and Manufacturing Organization (CDMO), ADVAXIA Biologics. ADVAXIA is authorized to produce investigational medicinal products by the Italian National Regulatory Authority (AIFA) and is compliant with the FDA More ❯
sufficient for an individual to meet the requirements of the role. Required Skills/Experience Process Automation : Experience in automation within the biopharmaceutical or pharmaceutical industry or another industry. GMP experience required. Good understanding of the biopharmaceutical/pharmaceutical development process. Expertise in commissioning and validation of automation systems. Understanding of device networking and communication protocols. Experience in installing and More ❯
basic understanding of computer system validation in the pharmaceutical sector Experience and knowledge of working in a regulated environment, specifically with regards to record retention Knowledge of GCP and GMP with regards to QMS activities Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures Responsible … for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions are closed timely and in a RFT state Job Background Minimum of 3 years experience working in More ❯
Holbeach, Holbeach St Marks, Lincolnshire, United Kingdom
Bakkavor Group
achieved and improved upon, whilst taking a lead in generating and building a quality culture. Accountabilities: To participate and direct QA team to observe and audit production processes and GMP, ensuring products are made to specification and within customer codes of practice and Bakkavor standards - reporting findings to managers as appropriate To assist in delivery of site standards for visits … correct standard With guidance from Line Manager, manage QA activities required to deliver improvement of Technical KPIs e.g. audit of non-conforming processes, complaint investigations, update of swab schedules, GMP audits, glass, and plastic audits To plan and co-ordinate work of the QA team to meet requirements of the quality management system and the needs of the business ensuring More ❯
client based in South West London on a permanent basis. The ideal applicant will have an in depth pharmaceutical background with a strong knowledge of QMS, EU/UK GMP and EU/UK GDP guidelines. Spanish language skills are essential, at a professional level. Responsibilities Include: Ensure Quality Assurance (QA) business and regulatory requirements are met at all times … by all 3rd party suppliers, service providers and customers and Operational activities are compliant with authorised activities and scope detailed in the clients GMP and WDA licences. Co-ordinate the collation and review of supplier licences and certificates. Ensure medicinal products procured, held and distributed are as authorised by WDA of company, storage premises and customers. Manage authorised activities to … of importation performance monitoring. Qualifications: Degree level in a Life Science subject or equivalent in relevant experience. Knowledge of Quality Management system within a pharmaceutical background. Good understanding of GMP/GDP. Good understanding of pharmaceutical regulation and regulators. Good inter-personal and communication skills. Ability to work under pressure and to tight time deadlines. Excellent attention to detail. Ability More ❯
Spalding, Lincolnshire, East Midlands, United Kingdom
Bakkavor
achieved and improved upon, whilst taking a lead in generating and building a quality culture. Accountabilities: To participate and direct QA team to observe and audit production processes and GMP, ensuring products are made to specification and within customer codes of practice and Bakkavor standards - reporting findings to managers as appropriate To assist in delivery of site standards for visits … correct standard With guidance from Line Manager, manage QA activities required to deliver improvement of Technical KPIs e.g. audit of non-conforming processes, complaint investigations, update of swab schedules, GMP audits, glass, and plastic audits To plan and co-ordinate work of the QA team to meet requirements of the quality management system and the needs of the business ensuring More ❯
Worthing, Sussex, United Kingdom Hybrid / WFH Options
GlaxoSmithKline
intermediate product release while maintaining an efficient service in line with customer demands for the release of manufactured batches. Give advice and assistance across site on a range of GMP topics. May be expected to carry out GMP or corrective training. Review and approve documents as the Quality representative such as SOPs and technical reports. Support validation document review and More ❯
client's biotechnology start-up facility in North East England. This role offers the opportunity to be part of a high-performing automation team delivering critical systems in a GMP-regulated environment. Responsibilities: Executing FAT/SAT/IOQ protocols including generation of protocols and reports. Design, configure, and support Emerson DeltaV PCS and/or BMS platforms for bioprocessing … qualification, and validation of automation systems in collaboration with CQV and Operations teams. Participate in the development, testing, and deployment of automation changes, and maintain documentation in compliance with GMP requirements. Provide technical input during design reviews, FATs, SATs, and system walkdowns. Qualifications & Experience: Bachelor's degree in Automation Engineering, Software Engineering, or a related field. Prior experience in a More ❯
Pharmacy (or equivalent experience) - must be eligible to apply for QP within Belgium Experience Strong proven experience in the pharmaceutical industry Knowledge, Skills, Abilities Expertise in EU and US GMP requirements and guidelines Fluent in both English and French languages Excellent written and oral communication skills Proficient with MS Office Suite (Excel/Word/PowerPoint) Physical Requirements/Work … Environment This role involves working in a controlled manufacturing environment, adhering strictly to GMP guidelines to ensure product quality and compliance. Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture More ❯
a GMDP environment and a proactive approach to improving quality systems across the business. Key Responsibilities: Assist in the implementation and upkeep of the Quality Management System, adhering to GMP, GDP, and ISO standards. Ensure ongoing compliance with industry standards, regulations, and company policies. Foster a positive quality culture within the organization, supporting continuous improvement efforts. Contribute to Quality System … at meetings, and managing outcomes. Participate in audits (Regulatory, ISO, Client, Supplier, and internal) and manage CAPA plans. Skills and Experience: Proven experience and good working knowledge of GDP, GMP, and GPhC regulations, as well as ISO 9001 and ISO 13485 standards. Strong organizational and communication skills, with excellent attention to detail. Ability to take initiative and work under pressure More ❯
change management plans and executing change management interventions/tactics based on feedback and inputs from project and business stakeholders. Observes and supports all safety guidelines and regulations. Follows GMP and regulatory requirements, and ensures quality standards are met. Models the Company Mission, Vision and Values Statements, policies, and current standard business practices. Performs other related duties and or special More ❯
internal stakeholders (IT, Facilities, Engineering, Security, and Real Estate) and external consultants, contractors, and OEMs. Develop and maintain package scope, budget, schedule, and quality requirements. Ensure all systems meet GMP/GxP compliance, cybersecurity standards, and pharmaceutical industry best practices. Lead RFP processes, technical evaluations, and contract negotiations for IT/AV vendors and integrators. Manage interdisciplinary coordination with MEP More ❯
internal stakeholders (IT, Facilities, Engineering, Security, and Real Estate) and external consultants, contractors, and OEMs. Develop and maintain package scope, budget, schedule, and quality requirements. Ensure all systems meet GMP/GxP compliance, cybersecurity standards, and pharmaceutical industry best practices. Lead RFP processes, technical evaluations, and contract negotiations for IT/AV vendors and integrators. Manage interdisciplinary coordination with MEP More ❯