Associate Specialist Quality Assurance Systems
vor 1 Monat
Job Description
Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that's devoted to delivering a high-quality, reliable supply to customers and patients on time, every time.
Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
For our site in Krems, we are currently looking for an:
Associate Specialist Quality Assurance Systems (m/f/d)
(Fixed term for 2 years, Full-time)
The Associate Specialist Quality Assurance Systems will be responsible for the quality aspects of key Quality systems with a focus but not limited to GMP computerized systems and supporting infrastructure to ensure compliance with company policies, procedures and regulatory expectations.
The position will work closely with stakeholders and subject matter experts ("SME's") from Site operations, Quality operations, Quality Control, IT, Automation and Engineering, Validation and Qualification.
The Associate Specialist must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.
Main Responsibilities:
- Support/drive maintenance and improvement of established Quality Systems
- Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and Company IT Owner)
- Providing the independent quality approval of key qualification and validation documentation to ensure compliance to company standards and applicable regulations
- Providing the independent quality review and approval of changes / deviations / compliance investigations, CAPA.
- Supporting regulatory inspection and audit activities.
- Driving resolution of regulatory non-conformance.
- Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.
- Promoting GMP awareness and a culture of continuous improvement and supporting manufacturing process improvements, laboratory operational excellence and validation activities.
Requirements:
- Bachelor's degree or other equivalent education, preferably in Engineering, Biotechnology or relevant experience
- Experience in a regulated pharmaceutical manufacturing and/or laboratory environment, Quality or Compliance role in GMP environment desired (FDA/EU/ICH)
- Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory or biotechnology manufacturing environment
- Operate as part of a self-directed team in carrying out day to day functions and assigning priorities
- Excellent oral and written communication skills including developing cross functional relationships
- Analytical problem-solving skills to issue identification and resolution
- Very good knowledge of MS-Office applications
- Fluency in written and spoken German and English
We offer an attractive salary, outstanding social benefits and an exciting work environment with varied tasks in an international environment. The minimum annual salary for this position is EUR 44.100,- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.
Current Employees apply HERE
Current 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:
Project Temps (Fixed Term)Relocation:
DomesticVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:08/03/2024
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.
Requisition ID:R287636
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