QA Specialist
Location: Ringaskiddy, Cork
Duration: 12 months
Hours: 39 hours per week
Pay rate range: Competitive hourly rate (PAYE, Umbrella and Ltd options available)
This position is responsible for carrying out tasks and projects related to the management of Quality Assurance activities at Janssen Biologics as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review, and Validation compliance activities.
Roles 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 following the J&J Standard of Leadership behaviour model.
* Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
* Batch Record Review & material release to ensure compliance with GMP requirements.
* Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
* Carries out tasks related to the management of batch records design and approval.
* Carries out administration of the SAP Quality Management Module.
* Carries out tasks relating to the management of site change control systems.
* Compiles Annual Product Reviews.
* Supports all validation activities on site as described in the Site Validation Master Plan.
* Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
* Supports system qualification and process validation activities.
* Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance.
* Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
* Participates in the introduction of new processes or modified process steps, as part of a New Product Introduction Team (NPI).
* Perform GMP audits on-site and vendor facilities as required.
* Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
* Carries out tasks related to the administration of site supplier approval process.
How to Succeed:
* 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 and Experience:
Essential:
* Bachelors Degree in a scientific/technical discipline required
* A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
* Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
Desirable:
* Experience in auditing of external suppliers, contractors, and vendors.
Benefits:
This role offers a very competitive hourly rate. This contract will run for a 12 month period and has a strong chance of extension.
Application Process:
We are looking to process the first round of applications within the next 2 working days. We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE, LTD & Umbrella options are available.
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