Director of Quality Assurance & QP

Established, Successful Pharmaceutical Manufacturers are Seeking to Add an Experienced Director of Quality Assurance Director, (DQA), to the Leadership Team

Reporting to the Chief Operating Officer, this is a Senior Leadership Role with Senior Professional Direct Reports

ROLE (Duties & Responsibilities Include)

• Ensure by Overall Management of the Quality Assurance Unit (QAU), that the Quality Management System (QMS) is Maintained and Operated in Full Compliance with All Current Applicable Requirements of Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), International Standards Organisation (ISO) 9001: 2008 and ISO 13485: 2003, Medical Devices Directive 93/ 42/EE, Medical Devices Regulations 2002, and UK Statutory Instrument 2002 No. 618, as Applicable
• Ensure that All QMS Sub–Systems are Maintained and Operated in Accordance with External and Internal Requirements, and Records are Maintained in a Functional, Effective, and Up to Date Manner
• Timely, Full and Adequate Support with Respect to Availability of Batch Manufacturing Records, and Other Documentation Required by Certifying Qualified Persons (QPs), for Batch Certification and Release Activities
• Fulfil the Primary Role in Hosting, Conducting, and Coordinating All Audits (Regulatory /Client) and Preparing and Responding to such Audits with Appropriate Corrective Action Preventive Action, and Ensuring Satisfactory Close Out
• Fulfil the Primary Role in Planning, Scheduling, Preparing, Executing, and Reporting of All Audits of External Manufacturers/Suppliers/Service Providers, and Ensure Follow Up and Close Out
• Primary Driver, with Support of Other Appropriately Qualified and Experienced QAU Personnel, in Maintenance of Awareness of All Current GMP/GDP/ISO Initiatives and Requirements, to Assess their Potential Impact Upon Operations, and to Coordinate and Prepare the Required Internal Arrangements and System and Procedural Changes to Maintain Compliance
• Perform the Duties of a Qualified Person in Accordance with the Provision of Directive 2001/83/EC and Provide QP Support for Site Issues, Expert Reports, Annual Product Reviews and Documentation, to Support License Applications/Variations and Product Release eg GMP Declarations
• Perform the Duties of a Responsible Person (RP) in Accordance with the Provision of Commission Guideline 2013/C 343/01 on Good Distribution Practice of Medicinal Products
• Support the QAU Manager – QPs for All Qualified Persons in Respect of Maintaining Awareness and Familiarity with the Overall QMS, in Resolving any QP Issues or Queries Relating to the QMS or the Functionality of the QMS, and to Host the Periodic, Routine Meetings with the QPs to Review and Assess Batch Certification and Release Activities, Including All Supporting QAU Activities and Reports, and Functionality of the QAU

REQUIRED (Essential)

• Suitable Bachelors or Higher Degree
• QP Status – EU Directive 2001/83/EC
• 7-10 Years’ Experience of Working in a Quality Management Role within the Pharmaceutical Sector

REMUNERATION

• £110K + Benefits Package

RESPOND

• Call Terry Blaney on +44 (0)1580 211221 to Learn More about this Career Opportunity or e-Mail terry@arxconsultancy.com with Your Application, Including Your Current CV