Regional QA Auditor
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.
For our Abbott Established Pharmaceutical Division (EPD) we are looking for a: Regional QA Auditor
The role of an EPD Regional QA auditor is related to the management of on-site audits and quality questionnaires of suppliers and third-party manufacturers under the responsibility of the EPD QA Regional LATAM team.
The scope are all the suppliers and third-party manufacturers providing materials, services, and products to EPD LATAM. Could be suppliers providing active principle ingredients, third party laboratories, commodities suppliers and third party manufacturers of intermediates or finished products for EPD.
Perform on site audits for suppliers and third-party manufacturers supplying materials/services to the region but located worldwide.
All the activities related to the audits assigned will require planning, preparation, execution, closure, and reporting.
Ensure all the information related to the Audit is documented n a timely manner in the system.
Manage Quality Questionnaire for supplies and Third-Party Manufacturers that provided materials/services to the region but located worldwide.
Assess the appropriateness and timeliness of proposed CAPAs, and track CAPA follow-up to close for supplier and TPMs evaluated.
Timely information on the audits to management and stakeholders. Escalation of any critical findings or negative audit outcomes to EPD LATAM regional senior management, in line with the applicable policy and procedures.
Reviewing any Quality Questionnaires returned by the Suppliers/TPMs and resolve any issues.
Read and extract developing regulations and trends from available sources to provide recent perspectives during audits.
Ensure a proactive determination of regulatory, compliance and quality issues and integrate them into audits/assessments on a priority basis.
Provide support to EPD LATAM plants in the timely resolution of issues related to suppliers. Discuss with and agree with the supplier a timely implementation of corrective and preventive actions, as needed to prevent recurrence.
Education & Background:
Bachelor Degree or equivalent level of education at a relevant scientific discipline (Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific), or industry experience with sufficient exposure to pharmaceutical or related industries.
Knowledge and understanding of the ICH and other relevant technical guidelines, as well as GMP guidelines.
Understanding of the WHO and other applicable regional and local regulations
Good Communication skills
Advanced written and verbal skills in Business English
Competencies required: adaptability, initiative, integrity, planning & organizing, information gathering, analytical thinking, interpersonal understanding, cultural sensitivity, ethical behavior, independence, decisiveness
Availability for traveling.
What can we offer you?
Abbott provides a varied, challenging, and international position in a dynamic and pleasant working environment. In our organization, you can count on excellent primary and secondary benefits, a positive working atmosphere, a personal growth plan, extensive training opportunities, and a good career perspective. We are in the business of advancement, both in health solutions and in the lives and careers of our employees. Our work across the world and in many areas of healthcare provides a rich environment for our employees to explore career paths, interests, and opportunities.
How to apply
Please apply by sending in your cv and motivation letter to this website, or directly to email@example.com, Attn: Niels Dijkstra. Applications will be assessed on a regular basis.
The base pay for this position isN/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:EPD Established Pharma
LOCATION:Netherlands > Weesp : WWA A-C-D
TRAVEL:Yes, 50 % of the Time
MEDICAL SURVEILLANCE:Not Applicable
SIGNIFICANT WORK ACTIVITIES:Not Applicable