QA Analyst
Posted By:
Laurie Chapman
Salary:
£22,595-£27,000
Location:
Cramlington
Job Type:
Temporary
Category:
Pharmaceutical
Central Employment is delighted to present an opportunity to work in a global pharmaceutical business. The opportunity will be working in the Quality Assurance team creating, monitoring and implementing Quality systems that are required in a pharmaceutical manufacturer. This is an excellent opportunity to join a leading business, understanding the importance of quality, compliance and the systems that underpin and create the foundations for all regulatory requirements. We are looking for candidates with a scientific degree, and looking to build a career in pharmaceuticals.
Key Responsibilities
- Provide Quality support for regulatory, global QMS and site QMS requirements.
- Responsible for preparing and reviewing documentation to support regulatory filings/renewals, source of supply changes, business submissions, tender bids.
- 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.
- Maintain systems to provide assurance to Site Management of ongoing compliance to applicable Organon and regulatory requirements, including:
- 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
Essential Requirements
- Degree in Chemistry, Pharmacy or other scientific field OR relevant experience
The Person
- Good written and spoken communication skills and ability to work in and lead cross-functional teams.
- Ability to form good working relationships with other functional groups.
- Attention to detail and well-organised approach to working.
- 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
