Senior Quality Assurance Advisor

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Job Introduction

Senior Quality Assurance Advisor

UK - HODDESDON

We are looking for:

A Senior QA Advisor to join our Drug Product Development team at our site in Hoddesdon. In this role you will be responsible for maintaining the day-to-day operation of the Quality Management System to support GMP manufacture of API and Drug Product.

At Pharmaron we offer:

• Vibrant and dynamic employment - we are a highly specialised, growth company operating in a critical sector of the economy - our future is strong and exciting!
• Opportunities to develop your skills and yourself - our rapid growth brings greater opportunities for you to learn and grow faster!
• A great team where we all support each other - enjoy your work - after all you spend about a third of your time here!

Key roles and responsibilities:

• To input/ propose/ modify departmental SOPs/ SPTs.
• To conduct internal Audits and to assist and support external audits by clients and regulatory authorities.
• Perform periodic reviews of Quality Systems including the generation of metrics.
• To support the Vendor Management process, performing Vendor Qualifications, Vendor Audits and Vendor Reviews.
• Investigate Deviations, Quality issues and trends and contribute to continuous improvement.
• Provides QA support on change controls and OOS.
• Follow up on CAPAs to ensure timely completion of actions and ensure status visibility.
• Write Quality Technical agreements with appropriate guidance and support.
• Support Qualification / Validation activities.
• Release materials for the production of GMP product.
• Review and approve Batch records.
• Provide Quality representation and input at project and planning meetings.
• Review and approve stability protocols and reports.
• Review trend reports for Purified Water, Environmental Monitoring.
• Perform Quality Risk Assessments.

Requirements:

Essential:

• Degree level qualification in Chemistry or related Scientific subject.
• Demonstrable experience in a Quality Assurance role within API/ Drug Product Pharmaceutical environment with experience within Oral Solid Dose (OSD) highly desirable.
• Thorough Knowledge of current GMP guidelines, including Eudralex Volume 4 Part I and Part II and ICH guidelines.
• Good communication skills with the ability to communicate effectively at all levels within a large organization.
• Strong interpersonal and relationship-building skills with the ability to influence and encourage a quality mindset.
• Excellent planning and organization skills - ability to multi-task, manage time and accept changing priorities.
• Work within and ability to effectively contribute to multidisciplinary scientific teams and environment.
• IT Skills with a good working knowledge of MS office.

Why Should You Apply?

• This is an opportunity for you as an experienced Quality Assurance professional to make a real impact in a highly scientific and regulated environment, demonstrate leadership, ambition and the desire to grow with the department.
• Build and shape your career in an environment that sets and commits to the highest standards.
• To be part of a team who support each other, embrace and solve technical challenges and put excellence at the heart of all that we do.