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Inhouse GMP Auditor EMEA (m/f)
- Leading international company with a European site based in Zurich
- New created position due to expansion of the QA Audit team
About Our Client
Our client is a global consumer goods company with several manufacturing plants and an extensive network of third party manufacturing partners and raw materials and packaging suppliers across Europe.
In the context of the expansion of the quality audit team, we are looking for a senior professional that will be part of the Global Quality Assurance Audit organisation and together with a colleague will be responsible for the complete QA Auditing activity across EMEA.
The position reports to the Global Quality Assurance Auditing Director and will have the scope of auditing not only the own production sites, labs and supply chain facilities, but mainly the third manufacturing sites, packaging materials suppliers, raw materials suppliers and third party testing laboratories.
The core aspects and challenges of the position would be the following:
- Define the audit objective, define audit requirements, schedule audits with suppliers, conducting opening and closing meetings and perform audits as the lead or co-auditor.
- Ensure that audits are conducted according to the company's policy and requirements, that every audit has a timely audit report issued and that corrective action/preventative action (CAPA) plans are identified for every audit.
- Update the audit tracking database with audit schedule, audit report and audit observations. Rank suppliers according to the company's risk profile. Participate in collecting and reporting the quality matrix that will determine the frequency and scope of new and re-audits.
- Close collaboration and interfacing with external quality audit companies that take a significant amount of audits done with suppliers.
- Collaborate with of members of the QA organisation and other functions within the company in continuous improvement of the audit program.
The Successful Applicant
We are looking for a senior candidate with at least 5 years of experience in a quality assurance audit role with availability to travel intensively across Europe (at least 60%).
We are selecting a candidate with a strong knowledge and expertise in regulations applicable to OTC drugs and cosmetics. These would include among other standards GMP / cGMP (specifically 21 CFR 210 and 211) , ISO 22716, and regulations from EFfCI and ICH (particularly Q7, that regulates Active Pharmaceutical Ingredients).
In terms of skills we are requesting a strong competence in the following:
- Team player and highly motivated to make a difference building collaborative relationships based on trust and respect. Promotion of the inclusion of diverse knowledge, skills, and experiences to achieve results.
- Capacity to embrace and initiate change, including the courage to lead changes that drive success
- Endeavor for excellence in execution, proactivity to seek ways to improve personal and organizational effectiveness to meet current and future business needs. Somebody who learns equally from successes and failures.
The working language of the company is English and we require an absolute business fluent English level for this role. Proficiency in additional European languages would be a plus. The job requires at least 60% international travel across Europe and sporadically Middle-East.
What's on Offer
Excellent opportunity to be part of a global team and develop further the QA Audit function across EMEA.