Overview
Job Title: QAA Writer– Global Biopharmaceutical
Contract: 12 months
Location: Slough (onsite)
Hours: 37.5 hours per week
QA is responsible for establishment, review and update of customer Quality Agreements (QAA) between the client and the Customer.
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 consistency between internal processes/standards and commitments in QAAs.
* Sets up an efficient system to track the completion status of QAAs and monitor requirements for periodic review; initiate periodic review where required.
* Executes establishment and maintenance of the QAA process within the company.
* 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.
Qualifications
* BSc in Science or QA discipline.
* Significant experience (5-10 yrs) working within a GMP-regulated pharmaceutical environment and/or relevant QA experience, ideally biologics or biopharmaceutical environments.
* Excellent communication skills (verbal and written).
* Excellent risk-based decision-making and problem solving skills.
* Ability to meet strict deadlines.
* Ability to work in a team and solo capacity.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Science and Quality Assurance
Industries
* Pharmaceutical Manufacturing
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