Quality Assurance Specialist

PE Global; Dublin; On-site; EUR 70,000 - 95,000; Full time

Job summary

PE Global is recruiting for a QA NPI Specialist for a leading pharmaceutical company in Dublin on a 12-month contract. You will deliver QA activities to ensure new products are introduced and manufactured to cGMP standards, partnering with Manufacturing, QC, QPs and Technical Services to secure patient supply.

The role requires a minimum of 5 years in a cGMP quality environment, strong knowledge of regulatory expectations (EU/FDA) and experience with QA documentation, audits and CAPA processes.

Qualifications

• Third level qualification e.g. B.Sc. in science/pharmacy.
• Minimum of 5 years’ experience in cGMP Quality environment.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing.

Responsibilities

• Quality Oversight on new product introduction in Bulk Drug Substance facility.
• Site QA responsibility to provide technical expertise for QA and compliance topics.
• Review and approve validation documents for equipment, software and qualifications.
• Support deviation investigations and CAPA proposals.

Skills

Quality Assurance

cGMP

Regulatory compliance

Auditing

CAPA

Documentation

Veeva Vault

Delta-V

Education

B.Sc. in science/pharmacy

Tools

Delta-V

Veeva Vault

Job description

PE Global is currently recruiting for a QA NPI Specialist on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12 month contract role.

Description:

• Responsible for delivery of quality assurance activities at the Dublin location to ensure New products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements.
• The Quality Assurance Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets.
• This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Manufacturing, QC, QPs, Technical services , Engineering and Planning to optimize patient supply.

Responsibilities:

• Quality Oversight on new product introduction in Bulk Drug Substance facility.
• Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to the manufacturing Facility.
• Review and Approve project documents involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others.
• Review and approval of validation documents for equipment, software and equipment qualifications, and others. (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
• Quality oversight on operations and technical services to review and approve Process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents.
• Review and Approve TRA’s, MSRs, SAP requests related to new products.
• Ensure all Materials are sampled and released as per the approved specifications and procedures.
• Investigation and approval of deviations generated encountered during qualification/validation testing.
• Participation in the project change control program and deviations for modifications to new and existing equipment.
• Provide guidance to project teams on Quality regulations for Validation strategy and approach.
• Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
• Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups.
• Provide sound QA and Compliance support to manufacturing, engineering, utilities, supply chain and material movement.
• Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
• Actively support audit readiness activities and regulatory agency and internal audits.

Education and Experience:

• Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• A minimum of 5 years relevant experience within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
• Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing.
• Excellent accuracy and attention to detail
• Good knowledge of relevant computer packages e.g. Delta-V, Veeva vault or similar
• High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***