MSD Associate Specialist Quality Assurance Systems m/f/d 

Austria, Lower Austria 

617632598

Job Description

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.

(asap, 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:

• Responsibility for one's own safety and that of the immediate environment.
• Act as Sub System Owner (SSO) for the Documentation System, responsible for maintaining and improving documentation quality system
• Perform duties related to Documentation and Records Management activities on site, including archiving
• Support Krems site users on e-ShopFloor (e-Log, e-SOP)
• As SSO responsibility, perform quality remediation actions such as creation, review and approval of relevant SOPs for documentation system
• Act as back-up for other quality systems
• Participate and support official inspections and self-inspections
• Contribute to the implementation of quality and compliance excellence for continuous improvement and increase in efficiency throughout quality and, where necessary, support initiatives at the site and company levels.
• Work collaboratively locally and globally to foster strong relationships with management and colleagues to drive a safe and compliant culture.
• Monitoring and communicating system health, compliance and other metrics updates to key stakeholders.

Requirements:

• Bachelor's degree or other equivalent education in (Bio)chemistry, Biology, or scientific field
• Experience in a regulated pharmaceutical manufacturing and/or laboratory environment, Quality or Compliance role in GMP environment desired (FDA/EU/ICH)
• Knowledge of EU GMP regulations as well as(V)ICH (VeterinaryInternational Conference on Harmonization) guidelines
• 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 46.305,- and varies according to the qualifications and experience of the successful candidate. We are looking forward to receiving your application.

Current Contingent Workers apply

*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.

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.