- Coordinate with area managers to ensure the site is 'inspection ready' in each of the areas by monitoring the site during regular site visits
- Ensure adequate preparation for all regulatory inspections, customer, and internal audits to include documentation and site personnel.
- Lead the 'Front Room' activities for all customer audits. Assist with front room facilitation for regulatory inspections, when required. Involve other site personnel as appropriate depending on the number of inspectors/auditors.
- Act as SME for the responsible areas as described in the job summary and address inquiries as appropriate.
- Coordinate the 'Back Room' activities during Regulatory Inspections, when required.
- Compose the formal responses to the audit observations with the assistance of area managers or designees.
- Ensure follow-up of the corrective action plans initiated after customer audits and regulatory inspections.
- Document all inspection activities within the TrackWise system according to required timelines.
- Facilitate the self-inspections management process
- Perform risk analysis to determine the content and schedule of the annual internal audits.
- Formalize the audit schedule ensuring that all six systems in the inspection model are considered including quality, production, facilities and equipment, laboratory controls, materials, and packaging/ labeling.
- Ensure adherence to the audit schedule, audit reporting, classification of deviations, development of responses and the implementation of actions.
- Provide continuous training for the internal audit team and facilitate professional training when necessary.
- Identify risk and evaluate deficiencies while working with internal departments/business units for remediation.
- Develop into the Subject Matter Expert (SME) for the site risk assessment process. Provide risk assessment training to site personnel, create, review, and/or approve risk assessments.
- Ensure remediation activities identified during the risk assessments are progressed and completed.
- Oversee the site change control system
- Evaluate the change control system and provide continuous improvement ideas
- Monitor the system to ensure that all stakeholder approvals, final approvals, actions items and closures progress according to timelines.
- Facilitate the weekly Change Control Committee meetings. Provide a plan for the upcoming week, ensure all necessary stakeholders are present, and drive for final approval of the change control.
- Review and approve all documents associated with the activities of the job description.
- Write procedures, protocols, reports, risk assessments applicable to the area
- Assist in procedure, protocol and report writing as necessary.
- Participate in the tracking and completion of CAPA's as required
- Support on-going continuous improvement activities of the site's Pharmaceutical Quality System.
- Bachelor's Degree in Life Sciences or related field
- Minimum 3-5 year experience in FDA regulated environment, preferably in a pharmaceutical manufacturing setting.
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FDA Quality Systems Specialist
1 week ago
Visron Technical Rochester, United States*JOB SUMMARY:* · The Quality Systems Specialist is responsible for managing all site inspections including regulatory agency inspections, customer audits and internal self-inspections. This position will support regulatory agency and customer audits by facilitating the 'Front Ro ...
Quality Systems Audit Specialist - Rochester, United States - Visron Technical
Description
Our client is a world leading contract development and manufacturing organization of pharmaceutical products. Located in France, the USA, Brazil, and China, we provide comprehensive innovation & development services to fulfil every aspect of contract pharmaceutical manufacturing needs. They specialize in unit dose manufacturing and our expertise includes an extensive range of unit dose packaging, such as Blow-fill-seal (BFS). In addition, we also manufacture preservative-free multidose, pharmaceutical bottles, sprays, tablets, tubes, suppositories and pessaries.
JOB SUMMARY:
The Quality Systems Specialist is responsible for managing all site inspections including regulatory agency inspections, customer audits and internal self-inspections. This position will support regulatory agency and customer audits by facilitating the 'Front Room' activities, writing the audit responses, and tracking all CAPA's associated with the responses. The role is responsible for managing the site risk assessment process including the identification of risk, evaluation of deficiencies, training and coaching on the risk process. The specialist will be responsible for the oversight of the site change control system which will include facilitation of the change control committee meetings, training, and coaching site employees on the change control process. In addition, the Quality Systems Specialist will support on-going continuous improvement activities of the site's Pharmaceutical Quality System.
DUTIES / RESPONSIBILITIES:
Manage regulatory inspections and customer audits
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