Senior Associate QA

4 weken geleden

Breda, Noord-Brabant, Nederland Orion Group Voltijd

Orion Group Life Sciences are looking for a Senior Associate QA (GMP) in the Product Complaints Inspection Team, on behalf of our Multinational Pharmaceutical/Biotechnology client located in Breda. Initial 12-month contract, with high possibility of extension. This is a hybrid role.

Main Responsibilities

  • Initiate and own Minor deviations related to Complaints Lab activities.
  • Provide QA oversight for Regulatory labelling in the WH.
  • Destruction Authorizations.
  • Own training material related to PCI processes.
  • Own work instructions related to PCI processes.
  • Prepare metrics and own and maintain departmental performance boards.
  • Perform assessments in support of complaint investigations (e.g. Reserve sample inspection, Return sample inspection and Safety Features verification).
  • Partner with corporate product quality surveillance, assessors from other sites of our client and contracted partners to resolve product complaint investigations.
  • Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
  • Assist in our clients' projects and improvement efforts as needed.
  • Provide training to ABR and our clients' affiliate staff on performing investigations/assessments.
  • Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.
  • Additionally, gain subject matter expertise in product complaint inspections and its related stakeholders.
  • For this role cross-training within other quality departments is warranted. This can include e.g. Plant QA, Warehouse QA, Clinical QA and other.

Requirements

  • Master's degree in Life Sciences or related field or the equivalent combination of education and/or experience.
  • Typically, a half year of related experience.
  • Experience in Quality Assurance in pharmaceutical industry.
  • Accurate mindset, flexible and pro-active attitude.
  • Fluent in Dutch and English language (preferred).
  • Understanding and application of principles, concepts, theories and standards of technical/scientific field.
  • Specialized knowledge within own specialty area.
  • Deepens technical knowledge through exposure and continuous learning.
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery.
  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope.
  • Ensures compliance within regulatory environment.
  • Develops solutions to technical problems of moderate complexity.
  • Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues.
  • Interprets generally defined practices and methods.
  • Works under general direction.
  • Work is guided by objectives of the department or assignment.
  • Refers to technical standards, principles, theories and precedents as needed.
  • May set project timeframes and priorities based on project objectives and ongoing assignments.
  • Recognizes and escalates problems.

If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, or contact Tim on

#opportunity #multinational #pharmaceutical #biotechnology #senior #associate #QA #qualityassurance #GMP #product #complaints #inspection

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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