QA Specialist-1421975W
Description
QA Specialist
Department: Quality Assurance
Report to: Quality Assurance Co-ordinator
Location: Janssen Pharmaceutical
Position Summary:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at JSCI as required by Good Manufacturing Practice (GMP). These activities include change control, nonconformance investigation, supplier qualification, incoming materials release, batch release, annual product review and validation compliance activities at JSCI.
Main duties and responsibilities:
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Carries out tasks related to the administration of site nonconformance management systems including review and/or approval of investigation.
Carries out tasks relating to the management of site change control systems.
Supports system qualification and process validation activities.
Supports GMP training activities.
Carries out tasks related to the administration of site supplier approval systems.
Carries out tasks related to the management of batch records design and approval.
Carries out administration of the SAP Quality Management Module.
Reviews and approves SOPs/work instructions/forms/validation plans form other departments on behalf of Quality Assurance.
Participates in Health Authority and Customer audits on site
Key Skills and Competencies required:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
• Decision making
Qualifications
Qualifications and Experience:
ESSENTIAL:
• Bachelors Degree in a scientific/technical discipline required
• A minimum of 2 years’ experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
DESIRABLE:
- Experience in development/ and or evolution of GMP systems.
- Operational experience.
- Experience in leading a project or team
- Experience in auditing of external suppliers, contractors and vendors.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Quality Assurance
Description
QA Specialist
Department: Quality Assurance
Report to: Quality Assurance Co-ordinator
Location: Janssen Pharmaceutical
Position Summary:
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at JSCI as required by Good Manufacturing Practice (GMP). These activities include change control, nonconformance investigation, supplier qualification, incoming materials release, batch release, annual product review and validation compliance activities at JSCI.
Main duties and responsibilities:
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Carries out tasks related to the administration of site nonconformance management systems including review and/or approval of investigation.
Carries out tasks relating to the management of site change control systems.
Supports system qualification and process validation activities.
Supports GMP training activities.
Carries out tasks related to the administration of site supplier approval systems.
Carries out tasks related to the management of batch records design and approval.
Carries out administration of the SAP Quality Management Module.
Reviews and approves SOPs/work instructions/forms/validation plans form other departments on behalf of Quality Assurance.
Participates in Health Authority and Customer audits on site
Key Skills and Competencies required:
• Excellent interpersonal skills
• Ability to operate as part of a team is critical.
• Customer focus
• Innovative
• Excellent communication skills both written and verbal
• Attention to detail
• Good problem solving skills
• Results and performance driven
• Adaptable and flexible
• Decision making
Qualifications
Qualifications and Experience:
ESSENTIAL:
• Bachelors Degree in a scientific/technical discipline required
• A minimum of 2 years’ experience in a quality, manufacturing, validation or compliance role within the biological and/or pharmaceutical industry.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
DESIRABLE:
- Experience in development/ and or evolution of GMP systems.
- Operational experience.
- Experience in leading a project or team
- Experience in auditing of external suppliers, contractors and vendors.
Primary Location:Europe/Middle East/Africa-Ireland-Cork-Cork
Organization: Janssen Biologics (Ireland) (8167)
Job Function: Quality Assurance