LSC have a requirement for a QA Specialist to join a leading biotech company based in Cork. For more than 25 years this company has been a global leader in the field of biomedicines, in particular pioneering monoclonal antibody technology a cutting-edge approach to producing medicines that launched a new generation of products to treat immune related diseases such as rheumatoid arthritis and plaque psoriasis.
As a QA Specialist you will:
o Batch Record Review & material release to ensure compliance with GMP requirements.
o Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
o Carries out tasks related to the management of batch records design and approval.
o Carries out administration of the SAP Quality Management Module.
o Carries out tasks relating to the management of site change control systems.
o Compiles Annual Product Reviews.
o Supports all validation activities on site as described in the Site Validation Master Plan.
o Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
o Supports system qualification and process validation activities.
o Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
As a QA Specialist you will need:
o Bachelors Degree in a scientific/technical discipline required
o A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
o 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.
o DESIRABLE: Experience in auditing of external suppliers, contractors and vendors.
Please contact Regina in LSC on 021 4777329 for further details on this role or apply directly through this advert.