Quality Systems Officer
Merck Sharp & Dohme Corp
Oss, NB, NL
7 uur geleden

QUA008179

For our Biotech Quality organization in Oss we are currently hiring an :

Quality Systems Officer Lvl1

About MSD

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.

Today, we are building a new kind of healthcare company one that is ready to help create a healthier future for all of us.

Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of an individual like you.

To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

MSD. Inventing for life. For more information, visit our website :

The organization

Quality Operations (around 120 people) at MSD Biotechnology Operations Oss has the following five sub-functions : Quality Assurance, Quality Systems, Quality IPT, Quality Control and Biological Critical Reagents Hub.

The Quality Department must ensure adequate quality systems are in place to support the manufacture, packaging, testing, storage, and distribution of products according to corporate policies, Guidelines, Procedures and regulatory requirements by appropriate oversight and monitoring.

For more information about MSD Biotech, please watch the MSD Biotech Oss video below.

The Position

The Quality Systems Officer L1 is responsible for active contribution to and continuing improvement of MSD Quality Management System and Site Compliance Plan throughout their knowledge and areas of expertise.

The main areas of expertise are in, but not limited to specific task and roles, internal and external inspection and auditing, supplier management including contracts and agreements, quality systems management, document / SOP management and intersite business, GMP Training & Knowledge Management, regulatory affairs and authority liaison function as well as other general specified tasks (e.

g. Site Master File, Manufacturing License).

Such using MSD’s Quality Risk Management tools and in line with MSD’s Lean and Operational Excellence methodology in a safe and compliant matter contribution to patients needs.

Auditing

Responsible for execution of all internal verification and system / process audit activities which are in line with relevant quality procedures, guidelines and directives to ensure Permanent Inspection Readiness and to monitor the status of GMP level, status and actions steps or other relevant performance indicators.

Inspection

Responsible for execution of all necessary means with regard to preparations, execution and follow-up on executed inspections at our manufacturing division Biotechnology Operations Oss.

Responsible for all necessary means with regard to Inspection relevant documents (Manufacturing License, GMP Certificate, Site Master File, Authority Accreditations)

Advice / Guidance

Responsible for providing advice / guidance to the functional areas on quality knowledge, procedures, guidelines and directives.

Responsible for supporting Continues Improvement and the supporting of the use MSD’s Quality Risk Management methodologies and tools encourages other to do so.

Responsible for supporting and monitoring decision-making and enable MSD CoE / IPT-members to retain, increase and test (through audits) the required / desired level of expertise.

Leads the Quality Risk Management efforts.

Documentation & Administration

Responsible for monitoring, initiating and ensurance of a compliant level of documents (including data) in a way that it can be used for periodical reviews (e.

Problem solving

Provides day to day support for MSD Biotechnology Operations Oss, raising concerns if needed or directing users to do so.

Training

Responsible for the support of our manufacturing division Biotechnology Operations Oss training initiatives and activitely contribute in the overall and current cGMP knowledge of all personell.

Develop and provide (organize) adequate actual training to personnel in line with the needs of the organization and in order to enhance the site level compliance.

Site related Compliance and Quality Agreement management

Responsible for Compliance and Quality Agreement of Site Services, Site Customers and MSD inter-Site activities.

EHS Responsibility

Responsible for actively contribution to realization of corporate policy on safety, health and environment. Demonstrate personal commitment with respect to working safely, healthy and environmentally friendly.

Internal :

All functional areas (IPT, CoEs and other MSD departments)

External :

Regulatory Agencies, Inspectors

Other MSD Sites and Global MSD Specialized Groups

Contract Manufacturing Organizations (CMO)

Contract Service Providers (e.g. Archiving, Logistics, Warehousing)

Qualifications

  • 0 5 years of relevant experience in the pharmaceutical industry and cGMP;
  • At minimum a bachelor’s degree (Dutch : HBO / HLO), preferable in Science or comparable work experience;
  • Continuous Learning Attitude;
  • Basic knowledge of relevant Quality and Compliance Guidelines (cGMP, Auditing, Quality Management Systems, Quality Agreements, Regulatory Affairs, Training), and respective regulations;
  • Basic knowledge of Quality Risk Management and tools, preferable Lean Six Sigma Yellow / Green belt trained;
  • Structured working skills;
  • Effective planning skills;
  • Computer literacy knowledge;
  • Strong focus on clients and end-user;
  • Ability to work under minimum supervision;
  • Team work oriented;
  • Flawless integrity mindset;
  • Ability to convert Quality mindset into practice;
  • Excellent interpersonal and communication skills, oral and written (Dutch and English);
  • Experience with document / quality management systems such as Sparta Systems Relevant Bachelor’s or Master’s degree (Science preferable);
  • A good place to work

    Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program.

    Our company’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives.

    Information

    For more information on the position please contact Joris-Jan Boons, Assoc. Dir, Quality Systems & Compliance Biotech Oss, by phone : +31 615546168.

    Application

    If you are interested in this challenging role, you are invited to apply online by uploading your resume and application letter in English or Dutch.

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