Specialist Quality Assurance IT Automation (m/w)

Datum: 19.01.2019

Location: Burgwedel, NI, DE

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Requisition ID: QUA007846

MSD 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 MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.


 


As part of the global QA IT team and reporting to the Associate Director of QA IT, we are looking for a Specialist Quality Assurance IT Automation (m/f) to join our team in Burgwedel (Full-time, 2 years).


 


The Specialist Quality Assurance IT will be responsible for:


 




  • The quality aspects of GMP computerized systems and supporting infrastructure used in site facilities, utilities, manufacturing, packaging, labelling, and laboratories to ensure compliance with company policies, procedures and regulatory expectations. This includes involvement in quality-related activities for computerized systems which are required by Our Manufacturing Division Quality Manual or with potential for impact on product quality, patient safety or data integrity


  • Collaborating with stakeholders (e.g. System Owners, Process Owners, Data Owner and Our Manufacturing Division IT Owner) to assess and select computerized systems to support GMP business processes; to ensure technologies selected meet the high-level business needs; and ensure the initial project tailoring is appropriate for the complexity and risk to accommodate the full scope of work


  • Providing the independent quality approval of key qualification/validation documentation such as policies, procedures, acceptance criteria, plans, protocols, requirements, reports and computerized system related changes to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle (including changes/modifications/deviations/variances/compliance investigations)   


  • Assuring site/above site system owners have Operating Level Procedures/Plans, approved by Quality, in place and routinely followed to ensure computerized system(s) remain in a validated status (e.g. problem and incident management, change control, periodic review, investigations, backup/restore, System Use and Administrative SOPs, disaster recovery plans, business continuity plans)


  • Reviewing processes and supporting documentary evidence to verify that compliance activities related to computerized systems are in place and effective


  • Supporting regulatory inspection and audit activities as needed.  This includes the review of audit or inspection reports, responding to findings related to IT applications, automated manufacturing equipment, automated lab systems and infrastructure (at local sites) and taking appropriate actions to ensure GMP compliance


  • Driving resolution of regulatory non-conformance for GMP computerized systems


  • Monitoring and communicating system health, compliance and other metrics updates to key stakeholders


  • Promoting GMP awareness and a culture of continuous improvement and facilitating manufacturing process improvements, laboratory operational excellence and validation activities, including latest trends in validation and best practices


  • Representing QA IT management upon request in local site or system specific meetings regarding computerized systems selection, operation and/or compliance related issues


  • Contribute in the development and maintenance of training programs in the principles of computerized systems validation and regulatory requirements in validation, maintenance and use of computerized systems
Qualifications

Qualifications:


 




  • Bachelor's degree.  Preferably Information Technology, Engineering or equivalent


  • Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing, IT infrastructure and/or laboratory operations


  • Experience in delivering validated IT solutions or an application support role


  • Good understanding of the current pharmaceutical industry and applicable regulations (FDA/EU/ICH), with emphasis in 21 CFR Part 11, 210, 211 and 820 and local regulatory expectations


  • Must demonstrate working knowledge of the principles, theories and concepts of computerized system validation/compliance


  • Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment


 


We offer:


 




  • An exciting opportunity within a stable and growing company


  • Development and career opportunities within the company


  • A competent, motivated and great team

 


Interested in becoming part of a dynamic, developing team and contributing your know-how to an innovative environment that allows you to show initiative and that offers long-term perspectives? Please apply using the link to our career site!


 


Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.


 


Search Firm Representatives Please Read Carefully: 


MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.



Job: Quality Operations
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD

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