Quality Specialist, Global Qta Management - Bathgate, United Kingdom - Catalent

Catalent

Verified Company

Bathgate, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

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.

The Role

To create draft customer specific QTAs, revisions or amendments to QTAs, utilizing approved template(s).
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 multisite or single site Customer QTAs.
To support tracking of QTA progress by entry of all new or change in status of the QTA document(s) within the shared tracking logs.
Write or revise Standard Operating Procedures (SOPs), SOP Work Instructions or SOP Forms
Support other CDS Clinical Global initiatives and other ad hoc duties as needed
Provide crossfunctional support within the CDS Clinical Supply Global team and CDS Clinical Supply sites when applicable.
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
Strong computer, written and verbal communication skills.

Computer Skills

Experience with Microsoft Word and Excel and management of Documents.
A selfstarter in nature, able to build relationships and work as a team.
High attention to detail
Strong written and verbal communication skills.
Must demonstrate proficient computer skills (Excel, Word, Access, and PowerPoint).

Why you should join Catalent:

Competitive Salary
Pension

Remote position

Monday to Friday
Opportunities to join Employee Resource groups and be involved in charity events

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. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.

As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety.

The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

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.