Principal QA Specialist

Role: Principal QA Specialist

Location: Slough, Berkshire SL1 4DX

Duration: 12 months

Must have experience

• Experience with implementation of PQS IT systems like Veeva Vault.
• Experience with documentation management

Top 3 must have skills

• Documentation writing skills
• Communication / collaboration
• Understanding of GMP compliance

Description:

• Enrolment and site maintenance of the global standards process.
• Support with the documentation management processes.
• Support with implementation of the global systems incl. preparation work, support with the validation and qualification activities, enrolment of the online training program, alignment with the stakeholders to ensure robust implementation of the system.
• Oversight of internal quality records to ensure they are completed on time
• Acts as a point of contact for general queries relating to new implemented systems.
• Alignment with the global project team to ensure the project is executed in a timely manner and as expected.
• Perform all business-related activities that may be reasonably requested and as instructed by the respective line manager and /or Senior Management Team.
• Takes personal responsibility for promoting quality culture.

Key Stakeholders:

• Please specify the stakeholder positions the role will interact with · Global QMS · QA Systems Team

Required Skills & Competencies:(e.g. technical, interpersonal, problem solving)

• Excellent communication and collaboration skills. Manages ambiguity through effective communication, removes barriers and overcomes resistance skillfully. Works in partnership as an active member of their team and cross- functional working groups.
• Exercises wide latitude in determining objectives and approaches to critical assignments. Is accountable for driving results, completion of improvement projects to address concerns both within and outside their department. Has the ability to determine correct actions and advice to address issues and needs. Make a conscious effort to expand and actively engage networks to drive results.
• Communicates regularly with peers/team members about customer topics to drive awareness and build capability. Is genuinely interested in understanding and embracing differences. Contributes to others’ success by offering support, providing feedback and sharing knowledge. Believes in the power of the team to get things done. Take responsibility for their safety and that of others. Contributes to a positive work environment. Acts as a reliable and dependable team member.
• High motivated, and results driven individual with very good understanding of assigned goals and their deliverables.
• Attention to details and corrective execution of the assigned tasks · Prioritizes workload to ensure deadlines are met.

Required:

• Bachelors of Science (or equivalent experience) Field of Study Science or QA discipline

Area:

• Minimum 5 years’ experience in the pharmaceutical industry in QA relevant roles.
• Advanced - 5-10 years
• Area Extended experience in implementation of IT PQS systems. Level Advanced - 5-10 year