Validation Coordinator - Global Operations Job in Ohio (OH), Manufacturing Career, Jobs in AstraZeneca Pharmaceuticals
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Validation Coordinator - Global Operations job in West Chester

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AstraZeneca Pharmaceuticals jobs
Ohio (OH), West Chester
Job Code:  R-035471
Employer:  AstraZeneca Pharmaceuticals
Category:  Manufacturing

Location
Country:  United States
State:  Ohio (OH)
City:  West Chester
Map: 
09/10/2018

Description
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

D e s cr i p t i o n :

The Validation Coordinator p e r f o r m s t a s ks i n su p p o r t o f t he p h a rm a ce u t i cal m a n u f a c t uri n g p r oc e s s e s a n d supp o r t s y s t e ms . P r o v i des validation support t o t he P r oc e ss E x ec u t i on T e a m (PET).

M a i nta i n t he m ast e r s i t e V a li d a t i on S ch e d ul e t o e ns u r e co n t i n u ed c o m p li a n ce and V ali d a t i on u ni q ue c r i t i cal e q u i pme n t / su p p li es.  Maintain the validation labs and calibrated equipment for continued use.

E s s e n ti al J o b F u n c t i o n s:

••    R e v i e w document a t i on n e e d ed f o r q u a li f i cati o n o f e q u i p m e n t a n d p r oc e s ses.
••    C o o r d i n a t e validation activities w i t h r e p r es e nta t i v es fr om PE Ts. S u p p l ement t he P E T staff duri n g e x ec u t i on t o e n sure p r o p er e q u i pme n t p l ac e m e n t ( p r o b es/ B I s / etc . )
••    C o o r d i n a t e w i t h P E T s t o m a n a g e v a li d a t i on d o c u m e n t a t i o n, scheduling and equipment availability .
• •     Track Validation Change Controls.
••    M a i nta i n e q u i pme n t a n d s y s t ems a l o n g w i t h t h ei r cer t i f i c a t i on r e cord s .
••    Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs
•       (Standard Operating Procedures), including general safety, lock outs, etc
• • C o o r d i n a t e q u al i f i cati o n acti v i t i es.
••    Work as a self-motivated individual in a team environment communicating effectively with all levels internal and external to the PET.
••    C r e a t e, e dit , a n d r e v i ew S O P' s f o r t he V a li d a t i on area.
• • A ss i st w i t h t r o u b l es h o o t i ng a n d p r oc e ss i m pro v e m e n t ac t i v i t i es.
• • R e a d t ec h n i cal p u b li cati o ns and m a n u al s.
••    Maintain calibration of Validation equipment and support cleaning validation activities through prep and facilitation for operator qualification.

Mi nim u m R e q u i reme n t s:

•    Hi g h school g r a d u a t e

• M i n i m um 4 y e a r s e x p e r i e n ce in a G M P r e g u l ated produ c t i on e n v i r o n m e n t

P re f erred R e q u i reme n t s:

•    A ssoc i ates o r B S i n a technical discipline

• W o r k i n g k n o w l e d g e o f M i c r os o f t a p p li cati o ns, S A P , a n d Tra c k w i se

•    E x p e r i e n ce w or k i ng i n a L EA N m a n u f a c t uri n g en v i r o n m e n t

• K n owl e d g e o f c G M P s a n d F D A p oli c i es/p r oc e d u r es

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law .  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe.

D e s cr i p t i o n :

The Validation Coordinator p e r f o r m s t a s ks i n su p p o r t o f t he p h a rm a ce u t i cal m a n u f a c t uri n g p r oc e s s e s a n d supp o r t s y s t e ms . P r o v i des validation support t o t he P r oc e ss E x ec u t i on T e a m (PET).

M a i nta i n t he m ast e r s i t e V a li d a t i on S ch e d ul e t o e ns u r e co n t i n u ed c o m p li a n ce and V ali d a t i on u ni q ue c r i t i cal e q u i pme n t / su p p li es.  Maintain the validation labs and calibrated equipment for continued use.

E s s e n ti al J o b F u n c t i o n s:

••    R e v i e w document a t i on n e e d ed f o r q u a li f i cati o n o f e q u i p m e n t a n d p r oc e s ses.
••    C o o r d i n a t e validation activities w i t h r e p r es e nta t i v es fr om PE Ts. S u p p l ement t he P E T staff duri n g e x ec u t i on t o e n sure p r o p er e q u i pme n t p l ac e m e n t ( p r o b es/ B I s / etc . )
••    C o o r d i n a t e w i t h P E T s t o m a n a g e v a li d a t i on d o c u m e n t a t i o n, scheduling and equipment availability .
• •     Track Validation Change Controls.
••    M a i nta i n e q u i pme n t a n d s y s t ems a l o n g w i t h t h ei r cer t i f i c a t i on r e cord s .
••    Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs
•       (Standard Operating Procedures), including general safety, lock outs, etc
• • C o o r d i n a t e q u al i f i cati o n acti v i t i es.
••    Work as a self-motivated individual in a team environment communicating effectively with all levels internal and external to the PET.
••    C r e a t e, e dit , a n d r e v i ew S O P' s f o r t he V a li d a t i on area.
• • A ss i st w i t h t r o u b l es h o o t i ng a n d p r oc e ss i m pro v e m e n t ac t i v i t i es.
• • R e a d t ec h n i cal p u b li cati o ns and m a n u al s.
••    Maintain calibration of Validation equipment and support cleaning validation activities through prep and facilitation for operator qualification.

Mi nim u m R e q u i reme n t s:

•    Hi g h school g r a d u a t e

• M i n i m um 4 y e a r s e x p e r i e n ce in a G M P r e g u l ated produ c t i on e n v i r o n m e n t

P re f erred R e q u i reme n t s:

•    A ssoc i ates o r B S i n a technical discipline

• W o r k i n g k n o w l e d g e o f M i c r os o f t a p p li cati o ns, S A P , a n d Tra c k w i se

•    E x p e r i e n ce w or k i ng i n a L EA N m a n u f a c t uri n g en v i r o n m e n t

• K n owl e d g e o f c G M P s a n d F D A p oli c i es/p r oc e d u r es

Next Steps - Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law .  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

ref: (R-035471)
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