Associate Specialist, Quality Assurance Documentation (m/w/d)
MSD Malaysia
- # Associate Specialist, Quality Assurance Documentation (m/w/d)Applyremote type: Not Applicablelocations: DEU - Bayern - Unterschleissheimtime type: Full timeposted on: Posted Todaytime left to apply: End Date: July 24, 2026 (29 days left to apply)job requisition id: R403098Job DescriptionUnsere Qualitätssicherung gewährleistet, dass alle in unseren Produkten enthaltenen Materialien und Stoffe unter Einhaltung unserer strengen Qualitätsstandards und aller behördlichen Auflagen hergestellt, verarbeitet, geprüft, verpackt, gelagert und geliefert werden. Durch die enge Zusammenarbeit unserer unternehmensinternen Produktionsstätten und Kooperation mit externen Herstellern und Zulieferern schaffen wir ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht hat, Kunden und Patienten weltweit in jedem Einzelfall zuverlässig und pünktlich mit Produkten zu beliefern, die den hohen Qualitätsstandards genügen.Zur Verstärkung unserer operativen Qualitätseinheit am Produktionsstandort in Unterschleißheim suchen wir zum nächstmöglichen Zeitpunkt einen **Associate Specialist, Quality Assurance Documentation (m/w/d**).Standort: Unterschleißheim (bei München) | Vollzeit.**Ihre Aufgaben:*** cGMP gerechter Review der Chargendokumentation und Vorbereitung der Dokumentation für die Freigabe* Durchführung der SAP Transaktionen sowie Archivierung der Dokumente* Erstellung von Zertifikaten* Erarbeitung von Vorschlägen zur kontinuierlichen Verbesserung der Freigabeprozesse bzgl. Effizienz und Effektivität* Erstellung und Pflege von SOPs für den entsprechenden Aufgabenbereich* Erfassung und kontinuierliche Verbesserung von qualitätsrelevanten Kennzahlen* Unterstützung bei Vorbereitung und Organisation von Behördeninspektionen (Back-Office)**Ihr Profil:*** Abgeschlossene Berufsausbildung im Pharma-Bereich oder Bachelorabschluss im naturwissenschaftlichen Bereich* Erfahrung in der Pharmaindustrie, insbesondere GMP-Anforderungen hinsichtlich Dokumentation von Vorteil* Fließende Deutschkenntnisse sowie gute grundlegende Englischkenntnisse in Wort und Schrift* Zuverlässigkeit, Kunden- und Ergebnisorientierung, Planungs- und Organisationsgeschick* Exzellente Teamfähigkeit und sehr gute kommunikative Fähigkeiten* Flexibilität und BelastbarkeitDas erklärte Ziel unseres Unternehmensbereichs Produktion & Lieferung ist es, als weltweit zuverlässigster Hersteller und Lieferant von Biopharmazeutika zu agieren. Unsere Produktionsstätten bilden gemeinsam mit unseren externen Auftragnehmern, Zulieferern und Partnern ein eng verflochtenes globales Produktionsnetzwerk, das es sich zur Aufgabe gemacht hat, Kunden und Patienten in jedem Einzelfall zuverlässig und pünktlich mit qualitativ hochwertigen Produkten zu beliefern.Wir sind stolz darauf, ein Unternehmen zu sein, das auf den Werten seiner vielfältigen, talentierten und engagierten Mitarbeiter aufbaut. Der schnellste Weg innovative Entwicklungen voranzutreiben ist, unterschiedliche Ideen in einer integrativen Umgebung zusammenzubringen. Wir bestärken unsere Kollegen darin, sachlich über ihre Vorstellungen zu diskutieren und Probleme gemeinsam anzupacken. Wir sehen uns als Arbeitgeber der Chancengleichheit und engagieren uns dafür, integrative, vielfältige Arbeitsplätze zu fördern.**Required Skills:**Analytical Problem Solving, Analytical Problem Solving, Aseptic Filling, Back Office Systems, Biopharmaceutical Industry, cGMP Compliance, Clinical Chemistry, Complaint Management, Decision Making, Deviation Management, Good Manufacturing Practices (GMP), Pharmaceutical Microbiology, Pharmaceutical Process Engineering, Pharmaceutical Sciences, Pharmacogenetics, Quality Assurance (QA) Standards, Quality Assurance Processes, Quality Auditing, Quality Control Documentation, Quality Management Standards, Quality Management Systems (QMS), Quality Standards, Quality Support, Root Cause Analysis (RCA), Team Management {+ 1 more}**Preferred Skills:**Current Employees apply HERECurrent Contingent Workers apply HERE**Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.**Employee Status:**Regular**Relocation:**No relocation**VISA Sponsorship:**No**Travel Requirements:**10%**Flexible Work Arrangements:**Not Applicable**Shift:**Not Indicated**Valid Driving License:**No**Hazardous Material(s):**N/A**Job Posting End Date:**07/24/2026**\*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- J-18808-Ljbffr MSD Malaysia
Vacancy posted 6 hours ago
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