QA Specialist, QC Testing & Systems (12M, Limerick)

CareerWise Recruitment; Limerick; On-site; EUR 55,000 - 75,000; Full time

Job summary

CareerWise Recruitment is seeking a QA Specialist with a strong background in QC testing and QC systems (LIMS, Empower) for our multinational Life Sciences client in Limerick. This is a 12-month, fully on-site contract located in Limerick.

The role requires 3+ years in QC Testing with experience in LIMS/Empower. Note: No sponsorship is provided; applicants must have Irish/EU citizenship or the relevant Stamp/Visa in place.

Qualifications

• Assoc Specialist - BS/BA in scientific discipline or related field
• Specialist - BS/BA in scientific discipline with 2+ years of relevant work experience in pharmaceutical or related industry
• Sr Specialist - BS/BA in scientific discipline with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry

Responsibilities

• Responsible for ensuring compliance with all aspects of Quality for the site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborates with Cross functional teams to resolve issues, complete investigations and maintain compliance.
• Responsible for review and approval of the following types of documents: Failure investigations; Corrective and preventative actions (CAPA); Standard operating procedures (SOP's); GxP documents.
• May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
• Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Monitoring and trending metrics associated with site quality systems.
• Actively participate in continuous improvement ideas, initiation, and implementation.
• May participate in internal, regulatory and customer audits.
• May train personnel on quality system processes.
• Perform additional duties as requested.

Skills

QA testing

Quality systems

cGMP knowledge

Investigations & CAPA

Education

Assoc Specialist - BS/BA in scientific discipline

Specialist - BS/BA with 2+ years in pharma QC

Sr Specialist - BS/BA with 5+ years or MS 4+ years

Tools

LIMS

Empower

Job description

QA SPECIALIST with a strong background in QC Testing and associated QC Systems (for example LIMS, Empower) required by CareerWise Recruitment for our multinational Life Sciences client in Limerick.

Initial 12 month contract...fully on-site role in Limerick.

LIMS and/or Empower industry experience required.

Ideally suit a QC Analyst OR QC Specialist with 3+ years experience in QC Testing (and experience in associated QC Systems).

NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Responsible for ensuring compliance with all aspects of Quality for the site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
• Maintains regulatory compliance in accordance with current Good Manufacturing Practices (cGMP).
• Collaborates with Cross functional teams to resolve issues, complete investigations and maintain compliance.
• Responsible for review and approval of the following types of documents:
• Failure investigations
• Corrective and preventative actions (CAPA)
• Standard operating procedures (SOP's)
• GxP documents
• May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver.
• Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.
• Monitoring and trending metrics associated with site quality systems.
• Actively participate in continuous improvement ideas, initiation, and implementation.
• May participate in internal, regulatory and customer audits.
• May train personnel on quality system processes.
• Perform additional duties as requested.

Education and Experience:

• Assoc Specialist - BS/BA in scientific discipline or related field or equivalent combination of education and experience
• Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
• Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience