JOB DESCRIPTION:
For our Abbott Laboratories site in Zwolle we are looking for a:
QA Compliance Coordinator China Abbott Laboratories Zwolle
Are you detailoriented qualitydriven and excited about coordinating international regulatory and compliance projects At Abbott in Zwolle we are looking for a QA Compliance Coordinator China who ensures that our products processes and documentation meet all current Chinese regulatory requirements. You will play a key role in safeguarding quality safety and compliance across our global supply chain.
What will you do
Documentation & Filing:
Act as Subject Matter Expert (SME) for Chinarelated QA documents (e.g. Change Procedure China Recall Procedure Drug Quality Manual).
Prepare and maintain Chinaspecific documentation (forms templates reports).
Update batch work orders in line with filing and registration requirements.
Ensure compliant document control (versioning approvals archiving) according to the site Quality Management System (QMS).
Regulatory Implementation
Review new or amended China regulations and summarize their impact for the Zwolle site.
Coordinate implementation projects (gap assessment action plan closure).
Contribute to Chinarelated regulatory training and deliver site training when needed.
Support evaluations and interpretations of China regulations.
Compliance Upgrades
Prepare and implement quality system documentation as part of our journey toward full China compliance.
Lead smaller project workstreams or support larger crossfunctional compliance projects.
Document and maintain the China drug policy and compliance roadmap for the Zwolle site.
Collaborate with Operations QA/QC Engineering and other functions on GMP food safety and audit programs.
Support internal audits host external audits/inspections and follow up on CAPAs and management reporting.
What do you bring
Bachelors/HBO degree in Life Sciences Food Technology Chemistry Microbiology Pharmacy or similar.
13 years of experience in QA Compliance or Regulatory within a manufacturing environment (food pharma nutrition or related).
Knowledge of quality systems and document control.
Understanding of regulatory pathways (change control recall filing) and eagerness to grow expertise.
Strong project coordination skills: planning tracking stakeholder followup.
Fluent in English and Dutch; Mandarin is an advantage.
Proactive detailoriented and comfortable working crossfunctionally.
Will you be our new QA Compliance Coordinator China Apply today and contribute to highquality trusted products that make an impact worldwide!
What do we offer
We offer a competitive salary. You will also receive an Individual Choice Budget (IKB) including holiday allowance 13th month special leave and additional vacation days.
How to apply
We look forward to receiving your application if you are interested in this position in working at Abbott and if you recognize yourself in the profile above.
You can apply with your CV and motivation through our website. Or contact Meltem Cakir at . We look forward to hearing from you as soon as possible.
The base pay for this position is
N/A
In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ANSC Nutrition Supply Chain
LOCATION:
Netherlands > Zwolle : Building 1
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
Required Experience:
IC
JOB DESCRIPTION:For our Abbott Laboratories site in Zwolle we are looking for a:QA Compliance Coordinator China Abbott Laboratories ZwolleAre you detailoriented qualitydriven and excited about coordinating international regulatory and compliance projects At Abbott in Zwolle we are looking for a Q...
JOB DESCRIPTION:
For our Abbott Laboratories site in Zwolle we are looking for a:
QA Compliance Coordinator China Abbott Laboratories Zwolle
Are you detailoriented qualitydriven and excited about coordinating international regulatory and compliance projects At Abbott in Zwolle we are looking for a QA Compliance Coordinator China who ensures that our products processes and documentation meet all current Chinese regulatory requirements. You will play a key role in safeguarding quality safety and compliance across our global supply chain.
What will you do
Documentation & Filing:
Act as Subject Matter Expert (SME) for Chinarelated QA documents (e.g. Change Procedure China Recall Procedure Drug Quality Manual).
Prepare and maintain Chinaspecific documentation (forms templates reports).
Update batch work orders in line with filing and registration requirements.
Ensure compliant document control (versioning approvals archiving) according to the site Quality Management System (QMS).
Regulatory Implementation
Review new or amended China regulations and summarize their impact for the Zwolle site.
Coordinate implementation projects (gap assessment action plan closure).
Contribute to Chinarelated regulatory training and deliver site training when needed.
Support evaluations and interpretations of China regulations.
Compliance Upgrades
Prepare and implement quality system documentation as part of our journey toward full China compliance.
Lead smaller project workstreams or support larger crossfunctional compliance projects.
Document and maintain the China drug policy and compliance roadmap for the Zwolle site.
Collaborate with Operations QA/QC Engineering and other functions on GMP food safety and audit programs.
Support internal audits host external audits/inspections and follow up on CAPAs and management reporting.
What do you bring
Bachelors/HBO degree in Life Sciences Food Technology Chemistry Microbiology Pharmacy or similar.
13 years of experience in QA Compliance or Regulatory within a manufacturing environment (food pharma nutrition or related).
Knowledge of quality systems and document control.
Understanding of regulatory pathways (change control recall filing) and eagerness to grow expertise.
Strong project coordination skills: planning tracking stakeholder followup.
Fluent in English and Dutch; Mandarin is an advantage.
Proactive detailoriented and comfortable working crossfunctionally.
Will you be our new QA Compliance Coordinator China Apply today and contribute to highquality trusted products that make an impact worldwide!
What do we offer
We offer a competitive salary. You will also receive an Individual Choice Budget (IKB) including holiday allowance 13th month special leave and additional vacation days.
How to apply
We look forward to receiving your application if you are interested in this position in working at Abbott and if you recognize yourself in the profile above.
You can apply with your CV and motivation through our website. Or contact Meltem Cakir at . We look forward to hearing from you as soon as possible.
The base pay for this position is
N/A
In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ANSC Nutrition Supply Chain
LOCATION:
Netherlands > Zwolle : Building 1
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Keyboard use (greater or equal to 50% of the workday)
Required Experience:
IC
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