QA Associate

Posted 8 Days Ago
Be an Early Applicant
Singapore
1-3 Years Experience
Biotech • Pharmaceutical
The Role
The Quality Assurance Associate will provide quality support to a Clinical Storage and Distribution facility in Singapore in line with PIC/S Good Manufacturing Practice and Good Distribution Practice. Responsibilities include material review and release, support on Quality matters, CAPA evaluation, Change Control review, validation document approval, batch record review, audit coordination, and more.
Summary Generated by Built In

Our Singapore facility is a strategic hub in the Asia Pacific region with 22+ years of expertise in the import/export, secondary packaging and labeling of clinical supplies, cold chain handling of temperature-sensitive products, and full returns and destruction management.

To support our growing activities we are looking for a Quality Assurance Associate to join our quality team. The associate will provide quality support to the Clinical Storage and Distribution facility in Singapore in line with PIC/S Good Manufacturing Practice and Good Distribution Practice. (GMP and GDP)

The role :

  • Perform review and release of materials, including therapeutic products intended for clinical trials and packaging components.
  • Evaluate CAPA effectiveness and identify process improvements.
  • Review and approval of Change Control, Complaints, and Deviation reports.
  • Approve specifications, sampling instructions and other Quality Control procedures.
  • Perform in-process checks during secondary assembly/ packaging activities and inspection of incoming materials, as required.
  • Perform batch certification in accordance with the principles detailed in Annex 16 of the PIC/S GMP Guide, and any other applicable guidelines or regulations.
  • Perform release of Finished Goods (after secondary assembly/ packaging activities).:
  • Maintain external/internal audit observation database and track observation response through to closure including a review of the corrective actions taken.

The candidate:

  • Diploma in sciences
  • Ideally, at least 2 years of experience in quality functions. Fresh graduates are encouraged to apply.
  • Good computer knowledge
  • Detailed-oriented with effective interpersonal skills.
  • Additional requirements:
  • Be able to work under cold (below 10C°) and frozen (below -10C°) for some hours (with PPE provided)
  • Be able to work at a height of maximum 4-5 meters routines as needed (with appropriate lifting equipment)

What we offer you

  • What we offer is an exciting role, a chance to grow and learn new skills in a global company
  • Potential for personal development within an international company
  • Defined career path and annual performance review and feedback process
  • Competitive salary
  • Company benefits package

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. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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 [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

The Company
HQ: Somerset, NJ
13,715 Employees
On-site Workplace
Year Founded: 2007

What We Do

Catalent Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs.

Catalent supports our partners in introducing 200 new products and manufacturing over 70 billion doses each year. Since becoming a publicly traded company in 2014, we have grown to become a community of approximately 19,000+ workers who support over 7,000 products for over 1,000 customers around the world. We share a common goal: to put patients first and help people around the world live better and healthier lives.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services to delivery technologies to supply solutions, we are the catalyst for your success. We have the deepest expertise, the broadest offerings, and the most innovative technologies to help you get more molecules to market faster, enhance product performance, and provide superior, reliable manufacturing and packaging results.

more products. better treatments. reliably supplied.™

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech, and healthcare companies, will help bring life-enhancing products to life.

Grow with us. Be challenged. Make a personal impact.

Visit https://careers.catalent.com/us/en to explore career opportunities

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