Manufacturing Quality Specialist

2 weeks ago

Bathgate West Lothian, United Kingdom Knewin Full time

Catalent is a global, high growth, public company and leading partner for the pharmaceutical industry in the development and manufacturing of the new treatments for patients worldwide. Your talents, ideas, and passion is essential to our mission: to help people live better, healthier lives.
We are looking for a QUALITY SPECIALIST, this role would be responsible for supporting the centralised Customer Quality Technical Agreement (QTA) process in accordance with international regulatory, company and GMP standards (Good Manufacturing Practice).
You will work within a cross-site organisational team to support the issuance of new Quality Agreements, amendments to Quality Agreements and revision to Quality Agreements.
To coordinate and communicate with the Business Development, Project Management and directly with the Customer and the Clinical Development & Supply (CDS) Catalent reviewers to facilitate the review and approval of multi-site or single site Customer QTAs.
Support other CDS Clinical Global initiatives and other ad hoc duties as needed
Bachelor’s degree in Business or Life Sciences preferred but not required


Relevant industry experience in the pharmaceutical industry. Quality or Regulatory areas preferred
Understanding of FDA and MHRA regulations pertaining to clinical packaging preferred
Understanding of pharmaceutical procedures
Candidate must be flexible, have well-developed organizational skills and have the ability to interact with all levels of management.
Strong computer, written and verbal communication skills.
Computer Skills – Experience with Microsoft Word and Excel and management of Documents.
Must demonstrate proficient computer skills (Excel, Word, Access, and PowerPoint).
Competitive Salary
Pension
Remote position – Monday to Friday
Catalent offers rewarding opportunities to further your career Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.This option is reserved for individuals who require accommodation due to a disability. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

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