Senior Scientist, Inspection & Audit
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Job Location:
Copenhagen - Denmark
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Our purpose is to bring hope to life by enabling life-changing therapies for patients around the globe creating a healthier and happier tomorrow. Our mission is to work side by side with our customers in order to improve patients lives by bringing new biopharmaceuticals to market.
At AGC Biologicswe arecommitted to a high standard of quality and execution - because we recognize that meeting the needs of our customers contributes to meeting the needs of providers and patients.As a global CDMO theInspection &Auditteam plays a vital role in managing regulatory inspections customer audits and internal audits.Being part of this team as a Senior Scientist gives you ahigh visibility role withasignificantscope and responsibility anddirect exposure to global regulatory authorities and key customers.Weoffer youan opportunity to own and shape the internal audit program and inspection readiness strategy with room to growand developin our global and GMP-regulated environment.
We Are BuildingTheTeamWith2 New Colleagues!
The Inspection & Audit team is part of the Quality Systems department and playsa central rolein the Quality organization at AGC Biologics.The team is looking for two highly experienced Senior Scientists to join our team onsite in Søborg just outside of Copenhagen.You will be joining a diverse team oftwohighlydedicatedSenior Scientists and one Studentwith several years of experience within quality assurance.Weenjoy being gathered forbi-weekly team meetings and GMP Grind sessions as well as breakfast on Thursdays andsocial activities!
We are actively involved in the continuous development and improvement of the quality system at our Søborg facility with close collaboration across our global AGC sites. The team works cross-functionally to ensure quality-related activities are carried out effectively efficiently and in compliance with cGMP with open communication professionalism and a genuine commitment to high-quality service at our core.
We Are TakingInspections &AuditsToTheNext Level
As a SeniorScientist you will be a key contributor in managing regulatory inspections customer audits and internal audits. You will play an active role in driving inspection readiness leading internal audit programs and spearheading quality improvement initiatives across the site. The core of this position lies in your ability tolead inspectionand auditactivities with confidence andexpertise and to translate experience into tangible quality is a senior role in every sense of the word if you recognize yourself as someone who would like to showcase your internal audit and inspection toolbox and take the team to the next level you may be exactly the colleague that we are looking for! Driving Inspections Internal Audits and Customer Auditswill be at the heart of what you do alongside driving continuous improvement:
- First of all we will trust you to be one of the driving forces of ensuringregulatoryinspectionsandinspectionreadiness.You will bepreparingthe organization for regulatory inspections (e.g.DMA FDA ANVISA MFDS) ensuring compliance with applicable regulations and standards as well as drivinginspectionreadiness activitiese.g.compliance risk assessments presenter preparation logistical infrastructure and staff training.
- Secondly you will beacting asLeadInternal Auditor. You will be planning leading and executinginternal audits across site functionsidentifyingcompliance gaps and systemicissuesanddrivingtimelyand effective resolution.Also we will encourage you tocontinuouslyimprovethe internal audit programe.g.scheduling execution follow-up andeffectiveness ofverification.
- Finally you will be trusted tomanage all aspects of customer audits from pre-audit preparation through to post-audit follow-up and CAPA management providing guidance to SMEs on addressing observations effectively before submission.Further you willfacilitate negotiate andmaintainQuality Assurance Agreements (QAAs)with customers ensuring alignment with regulatory requirements and internal quality standards and drivingtimelyreviews and updates.
- Overall taking theInspection& Auditteam to the next level requiresacommitment to continuous improvement. You will analyze trends toidentifysystemic issues lead cross-functional corrective and preventive actions and communicate regularly with senior management on outcomes risks and opportunities.
We Are LookingForAnExperienced Internal AuditorFromA GMP-Environment
You will be joining a highly skilled team who values yourscientificknowledge andinsights sobringing amasters degree in pharmacy biochemistry orarelatedlife sciences fieldgives you the ideal foundation.In order toconduct the above-mentioned auditsyou must have experience from internal audits or as an internal lead auditorinaGMP-regulated environmentofthe pharmaceutical biotech or medical device industry.Thisset of competenciestypicallytranslatesintoa minimum of5 years of experience.
Furtherit is an advantage ifyou bring solidknowledge of regulatory standards(e.g.EU GMP 21 CFR ICH)andprovenexperience in inspection readiness coaching SMEsthrough audit observations and the ability tocommunicate and negotiate confidentlyand clearlywith senior management regulatory authorities and customers supported byproficiencyin QMS and audit management tools.We know that this requires a key set of personal characteristics likediplomacy integrity critical thinking attention to detail and the ability to influence and collaborateacross functions. Finallywehighly appreciateif youbringexperience with Front Office and/or Back Office roles during regulatory inspectionsfacilitatingand managing QAAsanddriving quality improvement initiatives.
Would You LikeToMakeAnImpactOnTheInspections& AuditsOfOur Global CDMO
We hope that this opportunityhascaught youreyeand interest!Ifso applytoday andno later than April 19.PleasesubmityourCV including a short motivationat the top about whatimpactyou are motivated to makeonthis team and acrossAGC Biologics.If you haveanyLeadAuditor Certificates or similarrelevant documentation please attach it when you apply.We will review applications on a continuousbasis andexpect to conducttheinterview process during April and May withfirst round interviews in week 18 and second round interviews in week 19.We aim for a start date as soon as possible.If you have any questions before you apply you are welcome to contact theManager Joanna SadiqonWe are looking forward to hearing from you!
Our culture at AGC Biologics is defined by the six core values: Knowledge Trust Quality Ingenuity Accountability and Teamwork. Our core values stem from our team members and are embedded into our DNA. They provide a common language and understanding of how we as an organization are connected across three continents. Our core values serve as a compass and reminder of how we achieve our purpose of bringing hope to life for patients around the globe.
AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins plasmid DNA (pDNA) messenger RNA (mRNA) viral vectors and genetically engineered cells. Our global network spans the U.S. Europe and Asia with cGMP-compliant facilities in Seattle Washington; Boulder and Longmont Colorado; Copenhagen Denmark; Heidelberg Germany; Milan Italy; and Chiba Japan. We currently employ more than 2500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients most complex challenges including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more visit.Want to keep posted about our growth and learn more about our company Follow us on LinkedIn and give us a quick Like on Facebook!
AGC Biologics offers a highly competitive compensation package and a friendly collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age ancestry color family or medical care leave gender identity or expression genetic information marital status medical condition national origin physical or mental disability political affiliation protected veteran status race religion sexual orientation or any other characteristic protected by applicable laws regulations and ordinances.
Required Experience:
Senior IC
