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Overview:
TekWissen Group is a workforce management provider throughout the USA and many other countries in the world..This Client is a global animal health company dedicated to supporting customers and their businesses in ever better ways. Building on more than 65 years of experience, it deliver quality medicines, vaccines and diagnostic products, complemented by biodevices, genetic tests and precision livestock farming.
Position: Quality Assurance Professional
Location: Lee's Summit MO 64081
Duration: 6 Months
Job Type: Contract
Work Type: ONSITE
Job Description:
Good Distribution Practice Release: Review receiving documents and provide final approval.
When Sending Site QA, review and determine the impact of temperature excursions on product received in the LC and/or LSP by use of the available stability data. Determine adequacy of stability data in the final release of impacted product.
Perform stock release based on document review and/or manufacturing site QA final disposition.
Escalation to Management: Escalate incidents with impact to quality and/or regulatory compliance.
Labeling and/ or Relabeling :
Oversee relabeling and/or labeling processes performed at LCs and or LSPs. Ensure deviations are properly investigated. Follow up on CAPA.
Incident, Complaint handling/ Change Management:
Ensure events/ incidents, complaints related to SCL operations and Change Management records are documented.
Determine adequacy of CAPAs and completion to committments related activities by reviewing the reports.
Storage and Transport conditions: Review temperature records of storage and transport of Client Products and provide assessment to products impacted if temperature excursion occurs.
Risk Management:
Identify risks and assist on proposing actions for mitigation.
Escalate as applicable following Client process. Complete Risk Assessment Questionnaire of Suppliers and Contractors as applicable.
Experience:
3-5 years in quality at pharma or animal health industries.
Tek Wissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.
Full Time