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Manager QA/QP

Job description

 

Responsibilities

  • Responsible for leading and directing Quality staff including managing their performance and supporting their development.
  • Manage resource planning (e.g. shift roster, holidays) per business need
  • Responsible for achieving Plant QA Key Performance Indicators
  • Provide real-time QA oversight and support for production operations.
  • Collaborate with operations to resolve quality and compliance issues, including but not limited to Change Controls, NCs and CAPAs.
  • Ensures that changes that could potentially impact product quality are assessed according to procedures (ex: site change control, Maximo)
  • Review and approve cGMP records (e.g., Non Conformances, CAPA’s, electronic batch record, change controls, design qualifications, SOP, etc.) ensuring compliance with appropriate documentation
  • Alerts senior management of quality, compliance, supply and safety risks
  • Support and represent Quality during audits and inspections
  • Support Lean Transformation and Operational Excellence initiatives, drives continuous improvement initiatives within plant QA, and drive together with production management reduction of repeating events within plant QA and production.
  • Provides training and advice to staff in order for them to perform their desired functions.
  • Execute batch disposition

Authority

  • Decision in approval worked hours for contingent workers, holidays
  • Decision related to MAP process
  • Decision as Qualified Person as laid out in EU Directive 2001/83/EC

 Outputs

  • QA batch review and issue resolution (e.g. exceptions, NCs) to enable batch release within agreed timelines.
  • Batch Disposition within agreed timelines
  • Documentation, NC, CAPA, review and approval within agreed timelines

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

  • Thorough knowledge of the processes involved in clinical and commercial manufacturing.
  • Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) and GDP guidelines 2013/C 68/01 chapter 2.2 (Responsible Person).
  • Master’s degree in pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, biology or equivalent
  • Typically 2+ years of related professional experience
  • Sound knowledge of Good Manufacturing Practice and Good Distribution Practice
  • Relevant experience in dealing with Non Conformances and Change Control records
Skills and personality

Preferred Requirements

  • 3 years of professional experience in pharmaceutical environment (GMP)
  • 1 year managerial experience
  • Customer oriented and service minded
  • Experience in (bio)pharmaceutical production environment, in particular packaging and labeling
  • Good problem solving skills
  • Effective communication skills at multiple levels and areas (inside and outside of Quality)
  • Thorough decision making skills and  ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.

Competencies

  • Coaching
  • Communication
  • Decision quality
  • Problem solving – making complex decisions
  • Compliance rule-following attitude with high degree of attention to detail.
Contract

Executive search

Experience

minimum 3 years

Education

Master's Degree

Languages

Dutch, English

Sector

Pharmaceutical Packaging Industry

Region

Breda

Job type

Full-time

 
 

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