Welcome to Catalent, a global leader in providing advanced delivery technologies and development solutions for drugs, biologics, and consumer health products. We are currently seeking a highly qualified and experienced individual to join our team as a Qualified Person. As a Qualified Person at Catalent, you will play a critical role in ensuring the quality, safety, and efficacy of our products. We are looking for someone with a strong background in pharmaceutical manufacturing, regulatory compliance, and a passion for delivering innovative solutions. If you have a keen attention to detail, excellent communication skills, and thrive in a fast-paced environment, we would love to hear from you.
- Conduct thorough review and approval of all batches of drug products prior to release for distribution.
- Ensure compliance with all applicable regulatory requirements, including Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).
- Collaborate with cross-functional teams to develop and implement quality systems and processes.
- Conduct internal and external audits to assess compliance and identify areas for improvement.
- Provide guidance and support to manufacturing and quality teams to ensure adherence to quality standards.
- Review and approve all change control requests related to product manufacturing and testing processes.
- Investigate and document any product quality issues and implement corrective actions as needed.
- Stay up-to-date on current industry trends, regulations, and guidelines related to drug products.
- Serve as a point of contact for regulatory agencies and participate in regulatory inspections.
- Mentor and train junior team members on quality systems and processes.
- Participate in the development and maintenance of product specifications and analytical methods.
- Communicate effectively with internal and external stakeholders, including management, customers, and suppliers.
- Collaborate with R&D and business development teams to support product development and launch activities.
- Uphold company values and standards of professionalism in all interactions and activities.
- Continuously seek opportunities for process improvement and contribute to the overall growth and success of the company.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Cross-Functional Teams.
Bachelor's Degree In A Relevant Scientific Field Such As Chemistry, Pharmacy, Or Biology.
Minimum Of 5 Years Experience In A Pharmaceutical Or Biotechnology Manufacturing Environment.
In-Depth Knowledge Of Cgmp Regulations And Fda Guidelines.
Strong Problem-Solving And Decision-Making Skills.
Risk Management
Quality Assurance
GMP Knowledge
Auditing
Root Cause Analysis
Team Leadership
Regulatory compliance
Batch record review
Problem-Solving
SOP Development
Batch Release
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Qualified Person in Bathgate EH48, UK is £28,000 - £35,000 per year. However, salaries may vary depending on the specific job title, years of experience, and the company's industry and location. Some companies may also offer additional benefits such as bonuses, healthcare, and retirement plans.
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Catalent, Inc. is a multinational corporation headquartered in Somerset, New Jersey. It is a global provider of delivery technologies, development, drug manufacturing, biologics, gene therapies and consumer health products. It employs more than 14,000 people, including approximately 2,400 scientists and technicians.
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