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Remote Quality Assurance Associate
Remote Remote, IL 60062 US
Job Description
by supporting the following activities:
1) Annual supplier qualification
2) Support 3PL activities
a. Work Instruction Review/Approval
b. Nonconformance reports/Incident Reports Review/Approval
c. Quality discrepancy reports (Nonconformance Approval)
d. GDP QA input for Business Review Management
3) Upstream supply chain activities (product shipped from plants/suppliers to company 3PL)
a. Temperature Excursion Management, including but not limited to approval of temperature deviations for shipments sent to 3PL and update of the temperature excursion handling process
b. Product Damage Management, including but not limited to approval of deviations for shipments sent to 3PL and update of the product damage handling process
4) Document Management and archival of the GDP QA documents in Veeva/eQMS
5) Supports with any GDP related activities
REQUIRED:
1) BA / BS in a science field, with minimum 5 years of pharmaceutical industry experience, minimum 3 years of QA experience.
2) Knowledge of GDP and other relevant regulations, as required, with a broad knowledge of quality principles and industry trends.
3) Effective written and oral communication and interpersonal skills, facilitation, and influencing skills with an ability to effectively work across the company groups and with external stakeholders.
4) Must be a self-starter, proactive and have the ability to manage department resources to achieve the desired outputs on a daily basis.
PREFERRED:
1) Experience using GxP Documentation systems (Such as Trackwise (Digital), Veeva, SAP systems).
2) Direct experience in Quality Assurance function, GDP preferred
3) Working knowledge of global industry standards and regulatory requirements (e.g., US, EU and Japan).
4) Proficient with MS Excel, WORD, PowerPoint.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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