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Pharmaceutical Quality Assurance Specialist
2 months ago
Central Employment Agency (North East) Limited is pleased to present an exciting opportunity to work in a global pharmaceutical business. The role will be part of the Quality Assurance team, responsible for creating, monitoring, and implementing quality systems that meet the requirements of 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.
Key Responsibilities
- Provide quality support for regulatory, global quality management system (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 current Good Manufacturing Practice (cGMP) requirements.
- Maintain systems to provide assurance to Site Management of ongoing compliance to applicable Organon and regulatory requirements, including:
- General Methods
- Ensure governance and team compliance through company processes, business practices, and standard operating procedures (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 Ideal Candidate
- 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
