Sr Associate QA – Product Complaint Inspection (PCI) Breda • Talentmark

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Expectations/scope/complexity:

• Knowledge:
  • 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.

• Problem Solving:
  • 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.

• Autonomy:
  • 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.

• Contribution:
  • Contributes to work group/team by ensuring the quality of the tasks/services provided by self.
  • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup.
  • Provides training/guidance to others and acts as a technical/scientific resource within work group/team.
  • Establishes working relationships with others outside area of expertise.

Objectives:

• Perform complaint assessments in accordance with internal procedures, regulatory guidelines and business performance objectives.
• Own and/or act as QA contact for minor deviations.

Position Specific Tasks:

• Initiate and own Minor deviations related to Product Complaint Inspection (PCI) Area activities.
• 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. Return sample inspection and Safety Features verification).
• Partner with corporate product quality surveillance, assessors from other sites 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 projects and improvement efforts as needed.
• Provide training to ABR and 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.

Qualifications:

• The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.

Minimum Requirements:

• MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Knowledge of GMP and GDP with the ability to interpret and apply in both routine and non-routine cases.
• Knowledge of Complaints Management, Deviations and Quality processes and systems.
• Fluent in English Experience.
• Acquired practical experience in Good Manufacturing Practice (GMP) over at least 2 years.
• Acquired practical experience in Quality Assurance or related field in pharmaceutical industry over at least 2 years.
• Experience in investigations, deviations and Quality systems is a plus.