Job Title: QA Specialist II
Location: Slough (Onsite)
Duration: 5 months contract
Job Description
Role Purpose & Scope
* Working as part of QA system team, responsible for the implementation of global quality systems, including clean-up activities, on-site training, cross department communication, and preparation of initiatives.
* Additionally, overseeing the implementation and maintenance of global standards processes while supporting the management of documentation procedures.
Key Responsibilities
* Setting up and assisting in the implementation of new DMS and quality records global systems, including clean-up activities, preparation work, validation and qualification support, enrolment in the online training program, and alignment with stakeholders to ensure a robust system implementation.
* Provide regular updates on the project realization to line manager and/or Senior leadership team where required.
* Monitoring internal quality records to ensure timely completion, where applicable.
* Perform and support deviation or investigation where applicable
* Performing all business related activities as reasonably requested and instructed by the line manager or senior management team.
* Taking personal responsibility for fostering a strong quality culture.
Required Skills & Competencies
* Exercise broad discretion in determining objectives and approaches to critical assignments. Accountable for driving results, completing assigned tasks and addressing concerns both within and beyond their department. Possess the ability to determine appropriate actions and provide guidance to resolve issues and meet organizational needs. Actively expands and engages networks to drive results
* Highly motivated and result driven, with a strong understanding of assigned goals and deliverables
* Demonstrates keen attention to detail and ensures precise execution of assigned tasks.
* Priorities workload effectively to meet deadlines.
* Excellent communication and collaboration skills.
Qualifications
* Required: B.Sc or equivalent experience
* Field of Study: Life Science or QA discipline
Language(s)
* Required: English
* Ability Level: 2 - Business Fluent
Work Experience
* Area: Minimum 5 years’ experience in pharmaceutical or CDMO industry in QA relevant roles, Level: Advanced - 5-10 years
* Area: Extended experience in PQS systems, deviation, investigations, Level: Advanced - 5-10 years