Job Title: QAA Writer– Global Biopharmaceutical
Contract: 12 months
Location: Slough (onsite)
Salary: £31.52 PAYE, £41.10 Umbrella per hour (Inside IR35)
Hours: 37.5 hours per week
QA responsible for establishment, review and update of customer Quality Agreements (QAA) between the client and the Customer.
Job Responsibilities:
* Leads the timely establishment of customer Quality Agreements (QAA) between the client in Slough and the Customer.
* Acts as primary Point of Contact for Quality Agreements for the functional teams in Slough.
* Represents the client with regard to manufacturing and analytical testing in negotiations of Quality Agreements for both the internal network and the face to the customer.
* Provides the consistency between internal processes/standards and commitments in QAAs.
* Setting up an efficient system to track the completion status of QAAs and monitor the requirements for periodic review, initiate periodic review where required.
* Executes establishment and maintenance of the QAA process within the company.
* Participates in global QAA SOP revision working group.
* Improves currently existing tracking tools and established way of working.
* Creates new solutions in the field of QAA-related document life cycle.
* Provides training about the QAA structure and content to the functional teams.
Essential Requirements:
* BSc in Science or QA discipline.
* Significant experience (5-10 yrs) working within a GMP-regulated pharmaceutical – ideally biologics or biopharmaceutical – environments and/or relevant QA experience.
* Excellent communication skills (verbal and written)
* Excellent risk based decision-making and problem solving skills.
* Accurate data entry skills. Attention to detail.
* Ability to meet strict deadlines.
* Ability to work in team and solo capacity.