The Quality Manager is a new role reporting to the Director of Quality and Service. It is seen as a highly important role in an organization where quality and compliance are viewed as essential factors in of our success. The role is both inward- and outward-facing and will form a valuable part of our centre of expertise on relevant regulation and how this applies to our product.
The ideal candidate will have experience in Computer System Validation in a GMP environment.
· Delivery of quality and validation policies, procedures and work instructions that are compliant to FDA and MHRA regulatory expectations and in line with industry specific standards (GAMP/ISPE)
· Act as the Subject Matter Expert on Computer Systems Validation Ensure departments operate in compliance with all regulations relevant to our industry by conducting regular quality checks during specific stages of key processes.
· Oversight of CSV activities within product development and study delivery.
· Ensure departments operate in compliance with all regulations relevant to our industry by conducting regular quality checks during specific stages of key processes.
· Liaise with clients regarding quality and CSV related issues
· Coordinate customer RFI requests and client audits
· Manage supplier audits
· Conduct relevant internal audits
· Assist team members with resolution of work problems/investigations
· Be part of the company’s Customer Success Team and participate in critical discussions
· Actively keep up-to-date with relevant industry regulations
· Report to the Director of Quality Assurance any applicable data regarding the performance of the QMS and any other relevant matters
The ideal candidate will have the following skills:
· Bachelor’s degree or equivalent relevant experience
· Knowledge of GxP and quality systems
· Experience in a quality/CSV role
· Understanding CSV requirements within the pharmaceutical industry
· Strong verbal and written communication skills
· Excellent time management
This is a part-time role for working Mon-Fri.
25 day holiday for full time (40hrs work) which will also be pro-rated to match 25hrs/week working pattern