Description
Global Pharmaceutical company going through an exciting growth phase is seeking a QA officer for 6 month contract.Day to Day:
- Maintain site Quality Systems to support the manufacture and release of Combination products, including Training, SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review
- Provide QA support to site start-up activities by maintaining the site Inspection Readiness program.
- Review and participate in deviations and change controls to ensure appropriate investigation and assessment is carried out and actions implemented and monitored.
- Support/maintain operation of the site Training system, including preparing and presenting relevant training material, as required.
- Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.
- Keep abreast of regulatory initiatives and new guidance/requirements
Responsibility's:
- Educated to degree level (Life Sciences or Chemistry) with 5+ years industry experience.
- Working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
- Previous experience in maintaining Training and / or Vendor Management systems required
- Experience in designing and implementing quality or regulatory compliance systems and/or a start-up desirable
- Experience in or knowledge of inhalation dosage forms an advantage.
- High proficiency in Microsoft Word/Excel/Powerpoint/MS Project etc.
- Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
- Good team working and strong communication skills across functions and organization.
- An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
- Flexibility to learn new skills and take on new tasks and responsibilities.
- The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative
To hear more about the company and the role please contact me Anna Mooney or apply below with up to date CV.