Quality Auditor for Good Pharmacovigilance Practices (all genders) - part-time possible
Job Id: 282484
Location: Darmstadt, Hessen, Germany
Job Type: Full-time
About the Role
We are seeking highly motivated and self-starting individuals to join our diverse and engaged quality auditing team! This role offers visibility into our Research & Development function, with close interaction with various stakeholders. You will lead, coordinate, and participate in quality audits of different types (on-site or remote subsidiary/affiliate audits, vendor audits providing GVP services, process audits, and business partner audits) in the pharmacovigilance area globally. You will perform data analytics during the preparation phase, prepare meaningful audit plans, create audit reports, and follow up on audit observations. Additionally, you will support continuous improvement projects for the quality auditing function to ensure audits are conducted consistently in accordance with international and local Pharmacovigilance regulations and guidelines. You may also assist in inspection preparation and outcome follow-up.
Key Responsibilities
Lead, coordinate, and participate in various audits (on-site or remote subsidiary/affiliate audits, vendor audits, process audits, and business partner audits).
Perform data analytics during preparation, create standardized audit plans, and present audit observations.
Follow up on audit observations and support continuous improvement of the quality auditing function.
Ensure audits are conducted according to international and local Pharmacovigilance regulations and guidelines.
Assist in the preparation and hosting of inspections and follow-up on inspection outcomes.
Qualifications
Experience: Minimum 3-5 years of auditing experience in pharmacovigilance quality management and/or systems.
Knowledge: Comprehensive knowledge of Quality Assurance and auditing, with a focus on pharmacovigilance and additional GxP areas. Familiarity with GVP, ICH, US FDA, and EMA regulations.
Skills:
Strong planning, project management, and organization skills.
Ability to meet milestone deliveries under tight deadlines.
Service-minded and goal-oriented mindset.
Excellent intercultural and communication skills.
User knowledge in PowerBI, MS Office 365, and Veeva Vault QMS.
Excellent written and spoken English, with an additional language (preferably Chinese or Spanish).
Willingness to Travel: Up to 15% globally.
What We Offer
We celebrate diversity and believe it drives excellence and innovation. Our inclusive culture encourages personal growth, offering opportunities to develop at your own pace. Join us in building a culture of inclusion and belonging that empowers everyone to work their magic and champion human progress.
Apply now and become a part of our diverse team!
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Punjab :
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Delhi | India | New Delhi | PAN-India |Assam :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
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Frank Scottile Blvd |Missouri :
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Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
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Lake Charles | Shreveport |Nevada :
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New Hampshire |Oklahoma :
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Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Dún Laoghaire |Galway :
Galway |County Dublin :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
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Amsterdam |North Brabant :
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Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
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Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
North York | Uxbridge | Australia | Renfrew | Mississauga | Richmond Hill |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
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Koropi | Athens |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Remote Korea |Republic of Korea :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
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Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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