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Senior QA Officer

Job Type:


Senior QA Officer

Purpose of the Role:
• Responsible for reviewing in-house documentation in accordance with in-house specifications and cGMP.
• Works to maintain and manage quality systems regarding cGMP for the site.
• Supports or carries out audits and inspections to ensure compliance with Regulations.

Key Responsibilities:
• Reviews GMP or Regulatory documentation to ensure compliance.
• Liaises with internal or external third parties and may co-ordinate work done by different groups.
• Monitors third party compliance and follows up on non-compliance issues to ensure timely resolution or escalates appropriately.
• Take responsibility for investigating complaints.
• Provides advice and support to managers and resolves routine and non-routine compliance or Regulatory issues.
• May sign off some cGMP or Regulatory documents.
• Acts as departmental representative in projects or cross-functional meetings.
• Manages relevant systems and databases.
• Supports the continual improvement of processes and will be expected to generate new ideas for review.
• Has a good knowledge of cGMP, current legislation and regulations and how they impact on their activities.
• Keeps up to date with changes.
• May facilitate internal audits and inspections under directions and produce reports and action plans.
• Perform packed batch and bulk release activities.
• May act as product steward. Maintains knowledge of assigned product, including being the point of contact for the business for quality related advice and support for that product.
• May act as a point of contact for quality related advice and support for specific assigned functional areas.
• May act as a site standard owner.
• May act as a Quality IT System Co-ordinator.
• May provide training, coaching and supervision to less experienced QA staff.

• Work is supervised but has a reasonable level of independence within their field of knowledge.
• Organises time to meet short and medium term deadlines set by others.
• Will receive guidance from Manager or Project Leader when undertaking new tasks and projects.
• Will have some responsibility within a project team.
• Supports the successful completion of team and departmental goals and projects on time and in budget.
• Assists in meeting departmental objectives.

Knowledge, Skills and Experience Required:
• Typically a graduate or equivalent and may be working towards externally accredited qualifications.
• Demonstrated to successfully facilitate quality project work or audits. Demonstrated knowledge of working within a Quality Management System and cGMP.

Qualifications Required:
• BSc or equivalent is desirable.

At First Recruitment we understand just how important it is to secure the right people. That's why our consultants always take the time to understand requirements in detail and offer sound advice to both clients and candidates.

This is a superb opportunity for anyone looking to work for a reputable organisation.

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