Quality Assurance Specialist
Posted Today by LanceSoft UK
Negotiable
Undetermined
Onsite
Slough, England, United Kingdom
Summary: The QA Specialist II role in Slough involves working within the QA system team to implement global quality systems and manage documentation procedures. The position requires overseeing clean-up activities, providing on-site training, and ensuring compliance with global standards. The specialist will also be responsible for monitoring internal quality records and supporting investigations as needed. This is a 5-month contract position focused on fostering a strong quality culture within the organization.
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.
- 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.
Key Skills:
- 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.
- 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.
- Keen attention to detail and ensures precise execution of assigned tasks.
- Prioritizes workload effectively to meet deadlines.
- Excellent communication and collaboration skills.
- B.Sc or equivalent experience in Life Science or QA discipline.
- Business fluent in English.
- Minimum 5 years’ experience in pharmaceutical or CDMO industry in QA relevant roles.
- Extended experience in PQS systems, deviation, investigations.
Salary (Rate): undetermined
City: Slough
Country: United Kingdom
Working Arrangements: on-site
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
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