Quality Assurance Officer
Posted By:
George Hixon
Salary:
£31,000
Location:
Cramlington, Northumberland
Job Type:
Temporary
Category:
Pharmaceutical
Central Employment are thrilled to offer a 15 – 18 month maternity cover for a QA role in a global, world leading pharmaceutical business based in Cramlington. This role is to fill a maternity gap and requires extensive experience in a similar capacity. This is an excellent opportunity to join a large team working in a pivotal role for the organisation. cGMP understanding is an absolute necessity.
Candidates must have prior pharmaceutical experience
Key Responsibilities
- Provide Quality support for regulatory, global QMS and site QMS requirements. Proactively build Quality into site / department processes, systems and strategies to enable a state of permanent inspection readiness.
- Ability to lead and/or participate in projects liaising with internal and external customers / stakeholders effectively and efficiently. Lead and participate in compliance and continuous improvement activities.
- Develop proactive relationships with key stakeholders, (internally & externally) and perform all activities in accordance with cGMP requirements. Deputise for the QA Coach.
- Maintain systems to provide assurance to Site Management of ongoing compliance to regulatory requirements, including:
- Supporting Quality Unit Activities
- Lead Compendial review activities
- Lead Method transfer activities
- Analytical Standards (inc related analytical change requests) support
- General Methods support
- Supplier Acceptance program
The role will also:
- Be engaged in creating a vision & culture which links to business strategy and goals, promotes health and wellness, and rewards and recognises contributions.
- Set and achieve clear priorities, provide regular input through developmental 1:1’s, feedback and recognition.
- Ensure governance and team compliance through company processes, business practices and SOPs to deliver on business goals with the highest level of ethics and integrity.
- Take accountability for self-development; ensure understanding and application of policies and procedures to enable success for the organisation and to respond to the needs of the business.
- Provide Support with Audit/inspection requirements to ensure site and department compliance/readiness
- Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
- Be required to perform other duties as assigned.
QUALIFICATIONS, SKILLS & EXPERIENCE
- Previous experience in a Quality role.
- Experience in project management.
- Excellent understanding of practices and principles of up-to-date cGMP
- University degree in Chemistry, Pharmacy or other scientific or statistical discipline or equivalent.
- Strong Continuous Improvement mindset with experience and skills in the tools
The Person
- Ability to be decisive and influence across disciplines and all levels with demonstrated leadership skills to drive change in a compliance culture.
- Ability to lead and implement multiple projects/tasks simultaneously with competing and/or changing priorities; effective time management.
- Ability to influence areas not under direct control to achieve objectives and effectively communicate challenging goals.
- Ability to effectively initiate and drive change across multiple site functions
- Excellent written and spoken communication skills and ability to work in and lead cross-functional teams.
- A proven ability to form good working relationships with other functional groups.
- Attention to detail and well-organised approach to working
