PPD

Qualified Person

Company
PPD
Location
Athlone, Ireland
Salary
Competitive
Posted
07 Apr 2021
Closes
07 May 2021
Ref
1187632
Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Qualified Person - Athlone, Ireland

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health . You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

The role of a Qualified Person is to ove r se e s a ll f u nc t i o n s r e l a t e d t o the r e l ea se of pha r m a c e u ti c a l me dic i n a l prod u c t w ith r e qui r e m e n ts o f D ir e c ti v e 2 0 03 / 94 /E C ( H u m a n ) a n d i n v e stig a tio n a l me d i c i n a l pro d uc t, pl a c e bo or c om pa r a tor (if a pplic a bl e ) for a d e f i n e d cl i n i c a l st u d y u p on i m p ort a tion or r e -l a b e llin g , in a c c ord a nc e w ith t h e r e quire me n ts o f D ir e c ti v e 2 001 / 20 /E C a n d C l i n i c a l T ri a l Re gula t ion ( E U ) 5 36 / 2 0 14 .

Key responsibilities:
  • C e r t i f i e s b a t ch e s pr i or t o r e l ea se e n s u ring t h a t sp e c i f ic a n d d e t a il e d r e quire me n ts a n d r e gula t io n s h a v e b ee n m e t i nc l u d i n g t h e pr i nc ipl e s a n d guid e li n e s of G MP a s st a t e d in D ir e c t i v e 2 0 03 / 9 4/E C a n d t h e g e n e r a l c o n di t i o n s o n t h e M an uf a c t u r e r ' s L i c e n se or M an uf a c t u ring A u t h oriz a ti o n (issued b y t h e Irish Me d i c i n e s B o a rd) a re f ollo we d.
  • M a i n t a i n s u p - t o-d a te k n o w l e dge a n d e xp e ri e nc e i n th e light of te c hn i c a l a n d s c i e n ti f ic progr e ss a n d ch an g e s in quali t y ma n a g e m e n t r e l e v a n t t o the pr o d uc ts w h i c h t h e y a re r e quired t o c e r t i f y .
  • E n s u r e s t h a t Q u a li t y As s u r a nc e T e c h n i c a l A g r ee m e n ts a re set u p w ith t h e T r i a l Spo n s or.
  • P e r f or m s G MP f a c i lity a u di t s i n v ol v e d i n t h e man uf a c t u ring of me d i c i n a l p r od u c ts u sed in t h e c l i n i c a l st u d y .
  • Co m m un i c a t e s w ith Pro j e c t M a n a g e m e n t, Clin i c a l S u p p l y , Re gula t ory a n d Clin i c a l fu n c ti o n s i n t e r n a lly a s we ll a s w ith t h e T ri a l Spo n sor.
  • Se t s u p a n d ma i n t a i n s Pro d uc t Sp e c i f i c a tion F i l e s ( P S F) f or t h e me d i c i n a l prod uc ts t o be r e l ea sed f or a c l i n i c a l s t u dy as we ll a s a r e gis t e r or a ll r e l ea sed b a t ch e s.
  • D e v e lops a n d i m pr o v e s pr o c e dures r e l a t e d t o the QP r e l ea se process.


Qualifications:

Experience and Qualifications:
  • Bachelor's degree and Master's degree or equivalent with relevant formal academic / vocational qualification.
  • Suitable experience that provides the knowledge, skills, and abilities to perform the job
  • 5+ years' or equivalent combination of education, training, & experience.
  • Completed QP qualification and be eligible for QP status in EMEA.
  • Experience in biologics manufacturing would be distinct advantage.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture , where PPD truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organisation but with a local feel.
  • Pension scheme
  • Annual Leave 25 days
  • Medical Health care cover
  • Life Insurance

We have a strong will to win - We earn our customer's trust - We are gamechangers - We do the right thing -We are one PPD -

If you resonate with our five principles above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world's most urgent health needs, then please submit your application - we'd love to hear from you. 1

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

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