Quality Officer

Doorsturen
 
  • Aanbod Max. € 60,000
  • Functiegroep Engineering
  • Dienstverband Fulltime
  • Vacaturenummer 8583300
  • Locatie Oss
  • Contract Detachering via YER
  • Branche Medical & Health

Over deze vacature

The Quality Officer level 1 is responsible for providing advice, support and approval during:

  1. Root cause investigation and corrective and preventive actions
  2. Change control of procedures and processes

In addition, the Quality Officer level 1 reviews and approves standard production documentation and protocols and can act as a subject matter expert for the organization with regard to maintaining GMP compliance within the operational processes.

Functie

Main tasks:

  • Timely review and approval of protocols, reports and deviations in accordance with guidelines and local procedures
  • Acts as a subject matter expert for GMP compliance during root cause investigations, change control procedures and improvement activities and approves final protocols and reports
  • Ensures correct administration and documentation of data in accordance with guidelines and local procedures
  • Advocates safety culture within the organization
  • Indicates opportunities for improvement and takes part in projects in order to implement changes
  • Reviews and approves changes and associated documentation (i.e. change control, qualification/validation)
  • Monitors activities concerning compliance and ensures validated status of GMP processes and systems
  • Ensures that Quality policies, procedures and programs are properly implemented in daily GxP operations and remain up to date
  • Advises the production departments within IPT live regarding GxP compliance
  • Ensures on time resolution deviation investigations. - Reviews and approves deviation investigations
  • Participates in internal and external audits and projects as required
  • Supports MSD Animal Health training initiatives (i.e. development of training modules, actual training of individuals)
  • Supports (improvement) projects in IPT and QA-IPT live

Bedrijf

Today's MSD is the world leader in healthcare and contributes to a healthy world. With our medicines, vaccines, biological therapies and support services we offer innovative treatments for better health of people and animals in more than 140 countries. We are actively involved in better access to health care. We do this with extensive policies, programs and partnerships. Some 4500 employees work at MSD in the Netherlands at three different main locations.

Aanbod

We welcome you to a challenging, innovative environment with great opportunities for you to explore. You will be employed by YER and seconded to MSD.

Our benefits are very competitive and designed around your preferences:

  • A competitive salary depending on experience
  • Extensive set of tools to drive your career, such as a personal development budget, training and coaching
  • Healthy work-life balance

Profiel

  • Strong communication skills, both written and oral
  • Business proficient knowledge of Dutch and English language
  • Self-motivated and the ability to motivate others
  • Strong organizational skills and ability to manage multi tasks at one time, including the ability to follow assignments through to completion and meet timelines (commitment to task, attention to detail)
  • Strong safety awareness, able to identify potential safety risks and take responsibility in addressing the risks
  • Demonstrated ability to work as both a team player and independently
  • Skill in evaluating operations according to company and regulatory guidelines (policies, processes, procedures)
  • Pragmatism, ability to make decisions in a highly complex environment that balance business needs, quality and compliance risk and other constrains
  • Ability to manage and distribute workloads
  • Ability to provide direction and support goalsetting for individual staff members and work groups (planning/prioritizing/goal setting)
  • Drive for improvement, out of the box thinker, able to manage ambiguity
  • Resilience, ability to manage diversity and conflicting viewpoints
  • Higher education degree in a relevant area (HBO or equivalent)
  • At least 3 years of relevant Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with demonstrated experience in investigations, change control, validation and/or audits
  • Knowledge of Good Manufacturing Practice with the ability to interpret and apply in both routine and non-routine cases
  • Knowledge of manufacturing processes and operations
Doorsturen