Job Title: (Senior) GMP/GDP QA Auditor
Location: Allschwil
Company Overview:
The client company is a biopharmaceutical company that focuses on developing and commercializing medicines, particularly in the cardiovascular field and immunological disorders.
Responsibilities:
Ensure GMP/GDP compliance at third party service providers
Lead in establishing external QA Audit and internal self-inspection annual Plan
Conduct GMP/GDP audit and self-inspections and coordinate with internal personnel and suppliers to schedule, execute and follow up with audit observations
Promptly report critical self-inspection findings to the Responsible Person and Management
Create, implement, maintain, and work with Vendors on establishing Quality Agreements where needed.
Interface between quality/regulatory/compliance personnel and operations to identify applicable regulatory and compliance requirements and ensure accurate understanding of those requirements.
Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations (not project specific)
Write, review, and/or approve internal SOPs governing compliance related operations and other GMP/GDP and regulatory related documentation
Support the preparation of Regulatory Authority Inspections
Monitor changes in quality regulations and initiate required activities to maintain compliance of the quality system
Promote GxP and Quality mindset at all levels within the organization.
Candidate’s Requirements
University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum.
Minimum 3 years’ experience in Auditing, 1 as Lead Auditor.
Knowledge and understanding of drug product development, manufacturing processes, as well as quality control, packaging and distribution aspects.
Excellent knowledge of relevant GMP/GDP and international quality regulations e.g. ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP and ability to interpret and implement quality standards
Ability to work on multiple projects with various disciplines and to manage complex projects and prioritize workloads according to the project importance.
Strong attention to detail, excellent organizational skills, ability to multitask effectively, and confidence in interacting with individuals at all levels, from junior to senior.
Fluent verbal and written communication skills in English and at least basic knowledge of an additional European language e.g. German or French.
Experience in GCP Audits is a plus
If you are interested in learning more, please reach out to Mufaro Mpofu:
mufaro.mpofu@apsida.com
www.apsida.co.uk
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process
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