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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.
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