Description
My Client a pharmaceutical company based in Dublin, are seeking a QA Analyst to join their team for a 9n month contract.JOB PURPOSE:
To ensure that the Quality Systems within HBP are current, maintained, promoted and complied with in accordance with cGMP and batch release is carried out in compliance with the company's manufacturing licence and Investigational Medicinal Product licence.
JOB OUTLINE:
The job primarily involves but is not limited to the following duties:
*Reviewing development, IMP and commercial Production and QC records relating to the Oral Solid Dose (OSD) area to ensure that they have been filled out fully and correctly and that there are no discrepancies with respect to cGMPs, validated processes and manufacturing licences.
*Ensuring that above production and QC records are received and available for QP sign-off in a timely manner.
*Ensuring Quality Systems relating to the OSD area are in compliance with cGMP requirement and meet the expectations of US, EU and other relevant Regulatory Authorities.
*Identify and report with relevant department any gaps in Quality Systems or procedures and identify CAPA's to address such gaps.
*Review all facility, utility and equipment validation documents for completeness and identify any CAPA's to address deficiencies noted.
*Deliver periodic reports showing status of CAPA's proposed.
*Participating in Audits (Housekeeping, Internal Supplier, Regulatory and Customer), as required
*Coordinating/performing any required internal investigations/reports e.g. rejected batches, unusual results.
*Advising and providing input into quality systems across the plant as necessary.
The successful applicant will possess the following knowledge, skills, qualifications and experience.
*A minimum of BSc (Hons) Degree in a lifescience discipline
*At least 4 years experience working within a pharmaceutical manufacturing solid dosage environment with at least 2 years being in a Quality capacity.
*Excellent attention to detail with the ability to critically review analytical data and to write professional technical reports
*Experience of Quality systems to include but not limited to deviation, out of specs, QA KPIs etc.
*In addition, it is desirable that applicants would possess the following knowledge, skills, and experiences but these are not essential. Developmental training on the following can be provided
If you are interested in this great opportunity please contact me Anna Mooney or apply below with an up to date CV.