
Senior Specialist, Quality - Clinical Supply Quality
Welcome to AstraZeneca, a global biopharmaceutical company dedicated to improving the lives of patients around the world. We are currently seeking a highly qualified Senior Specialist in Quality to join our Clinical Supply Quality team. As a Senior Specialist, you will play a critical role in ensuring the quality of our clinical supply chain, helping to bring life-changing medicines to those in need. This position requires a strong background in quality assurance and experience in the pharmaceutical industry. If you are passionate about making a difference in the lives of patients and possess the necessary qualifications, we invite you to apply for this exciting opportunity.
- Oversee and manage all aspects of quality assurance for the clinical supply chain at AstraZeneca.
- Conduct regular audits and inspections to ensure compliance with internal and external quality standards and regulations.
- Develop and implement quality control processes and procedures to maintain the highest level of quality for all clinical supply operations.
- Collaborate with cross-functional teams to identify and address any quality issues or concerns in a timely and efficient manner.
- Review and approve all documentation related to quality, including SOPs, batch records, and validation protocols.
- Provide guidance and support to junior team members, ensuring their understanding and adherence to quality standards and procedures.
- Keep up-to-date with industry trends and regulations to ensure AstraZeneca remains in compliance and continuously improves its quality processes.
- Act as a liaison between the quality team and other departments to ensure effective communication and understanding of quality requirements and expectations.
- Participate in the training and development of employees on quality-related topics.
- Foster a culture of quality and continuous improvement throughout the organization.
- Collaborate with external partners and vendors to maintain high-quality standards for all clinical supplies.
- Monitor and analyze quality metrics to identify areas for improvement and implement corrective actions.
- Act as a quality expert and provide guidance and support to other departments on quality-related matters.
- Participate in cross-functional projects and initiatives to improve the overall quality and efficiency of the clinical supply chain.
- Adhere to all company policies, procedures, and regulations at all times.
Bachelor's Degree In A Relevant Scientific Field, Such As Pharmacy, Chemistry, Or Biology
Minimum Of 5 Years Of Experience In Clinical Supply Quality Within The Pharmaceutical Industry
Strong Knowledge Of Gmp, Ich, And Other Regulatory Guidelines Related To Clinical Supply Chain And Distribution
Proven Experience In Managing And Conducting Quality Audits And Inspections Of Contract Manufacturing Organizations (Cmos) And Third-Party Vendors
Excellent Communication And Problem-Solving Skills, With The Ability To Work Independently And Collaboratively In A Fast-Paced Environment.
Quality Assurance
Auditing
Quality Control
Root Cause Analysis
Good Manufacturing Practices (GMP)
Continuous Improvement
Risk assessment
Regulatory compliance
Supplier management
Process
Inspection Readiness
Communication
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Specialist, Quality - Clinical Supply Quality in Macclesfield, UK is £35,000 - £55,000 per year. However, this can vary based on factors such as experience, qualifications, and the specific company or industry the individual is working in. Additionally, salaries may also be influenced by the demand for professionals in this role in the local job market.
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AstraZeneca plc is a British-Swedish multinational pharmaceutical and biopharmaceutical company.

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