- Provides quality leadership, direction, and governance for the specific area of responsibility.
- Is responsible for approving appropriate quality-related documents.
- Carry out day-to-day activities in compliance with site safety policies and procedures. Promote and encourage safe practices & promptly report any safety concerns.
- Perform ongoing monitoring that includes
- Monitoring of quality systems,
- Production area time on floor audits,
- Verification of the effective implementation of key GMP programs,
- Review of systems that impact product quality to ensure that they operate in a state of control.
- Provide QA ownership for products manufactured in the area of responsibility.
- Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business-focused fashion.
- Maintenance of all aspects of GMP compliance for the area(s) of responsibility.
- Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents.
- Review and approval of change controls, observations, deviations, suspect analytical results and product quality complaints associated with the area(s) of responsibility.
- Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.
- Audit and participation in the site self-inspection program.
- Communication and education of personnel in GMP requirements and regulations related to the area(s) of responsibility
- Contribution to Annual Product Reviews, US Annual Reports, and Regulatory Submissions.
- Batch disposition, including approval of batch records, for API and Intermediate batches & approval of CoA's.
- BSc/MSc/PhD in Chemistry, Microbiology, Biochemistry, Biotechnology or a Science related subject.
- Additional Skills/Preferences
- Demonstrated excellent technical and problem-solving skills.
- Demonstrated strong interpersonal skills.
- Demonstrated strong verbal and written communication skills.
- Demonstrated ability to participate in and facilitate decision-making.
- Good IT skills and knowledge of standard software packages (e.g. Microsoft Word, Excel, SAP, Darwin)
- Demonstrated good planning and organizational skills, ability to prioritize tasks, commitment to task completion and timelines.
- Demonstrated initiative - able to work proactively without direct supervision, continuous improvement mind-set.
- Minimum of 2 years experience (associate to mid-level) as a QA Representative supporting Small Molecule production. Excellent understanding of the current pharmaceutical industry regulations (e.g. FDA, EU, ICH).
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