QA Specialist
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| Job Type | Contractor |
| Area | Dublin |
| Sector | Quality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | #1002294 |
| Job Views | 381 |
- Description
- If a Quality Assurance Specialist sounds like the job you'd be perfect for, we'd love to hear from you! As it happens, we are currently actively seeking candidates to fill this job. You’ll be looking after the delivery of quality assurance activities in Dublin location to making sure new products are introduced and manufactured in accordance with cGMP, corporate and regulatory requirements. The Quality Assurance Specialist delivers in order to protect the safety, quality and efficacy of products for our patients as well as assuring the security of the company’s business and global markets. You will be part of a dynamic team and working across other departments, locations and partnering with major stakeholders.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
The role is generously compensated, and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will bedoing:
Overseeing new product introduction
Giving technical guidance for all QA and compliance topics.
Reviewing and approving project documents
Collaborating cross-functionally.
Reviewing and approving of validation documents for equipment, software and equipment qualifications, and others.
Complying with current regulatory expectations, EU, FDA and corporate standards.
Managing quality on operations and technical services
Reviewing and signing off on process descriptions, sampling plans, operational procedures, process validation and cleaning validation documents.
Evaluating and accepting new requests related to new products.
Making sure materials are sampled and released appropriately.
Examination and approval of deviations made during qualification/validation testing.
Taking part in the project change control program.
Giving guidance on quality regulations for validation strategy.
Timely reviewing of documentation/investigations/reports highlighting
Helping in the resolution of issues commensurate with the level of risk
Making sure that schedules for review and approval of GMP documents are maintained to meet the needs of internal groups.
Giving support to internal departments e.g., engineering, utilities and supply chain
Helping with deviation investigations
Energetically helping support audit readiness activities and regulatory agency and internal audits.
What you need to apply:
Batchelor’s of Science in Science or Pharmacy
3+ years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
3+ years relevant experience within the pharma industry or a related field.
Excellent 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 is strongly desirable.
Past experience of GMP management within a pharma/biopharma company is essential.
Experience working to FDA, HPRA/EMA or other authorities of similar standing.
Excellent attention to detail
Good knowledge of relevant computer packages e.g., TrackWise or similar
Strong project management skills.
Great technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management.
Strong technical writing skills.
Brilliant interpersonal skills.
Excellent communication skills, verbally and written.
