Our client is recruiting for a number of QA officers to join their team. They will consider candidates of varied experience and the salary will reflect this.
Key areas of responsibility (include but not limited to):
- Originating, Approving and Issuing Production Documentation (Manufacturing & Packaging)
- Originating, Approving and Issuing Standard Operating Procedures (SOP's), in compliance with cGMP requirements
- Reviewing SOP's, as per review schedule
- Issuing Stability Documentation, approval of testing protocols, review of stability reports
- Reviewing Validation protocols & validation reports (including process validation, cleaning validation and equipment validation protocols and reports)
- Reviewing Product Development Documents
- cGMP training
- Internal and external auditing
- Investigating and review of deviations and out of specification results
- Investigating customer complaints
- Proofing and approval of artwork
- Maintaining ISO standards
- Liaise with customers for products which are contract manufactured
- Review Batch Documentation
- Any other projects relating to quality standards/requirements as assigned by Quality Assurance Manager/Quality Compliance Manager.
- Internal comment investigation
- Change control , vendor certification and approval of suppliers, raw material review
- Temperature monitoring
- CAPA reports
- FPS approval
- Support elemental impurities, excipient risk assessments, PQR reporting and production support.
- Educated Degree level - Chemistry, Pharmacy or Biological Science. with experience within the pharmaceutical industry, preferably within QC or QA or appropriate experience.
- Excellent organisational and time-management skills.
- Ability to leverage/collaborate effectively with internal and external stakeholders
- Excellent written and verbal communication and interpersonal skills.
- Strong problem-solver.
- Critical thinker.
- Comfortable working in a busy, fast paced regulated manufacturing environment.
- Comfortable working in a professional, team based environment.
Kelly Services are acting as an Employment Agency in relation to this role. Should you choose to apply, your information will be processed in accordance with Kelly's Privacy Statement. For information regarding data protection at Kelly, please visit the Kelly website and have a look into the Privacy Statement.
As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.