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The Quality Compliance Senior Specialist will play a key role in supporting and ensuring compliance with cGMP, FDA regulations, and other quality standards within our pharmaceutical manufacturing facility. This position requires strong analytical skills, attention to detail, and the ability to collaborate effectively with cross-functional teams.
Responsibilities and Accountabilities:
- Regulatory Compliance:
- Stay informed about current regulatory requirements and industry best practices to ensure continuous compliance.
- Collaborate with internal stakeholders to interpret and implement regulations relevant to pharmaceutical manufacturing.
- Prepare the necessary Documentation & inquiries to the Egyptian and foreign health authorities.
- Quality Systems Management:
- Support the development, implementation, and maintenance of the Quality Management System (QMS).
- Conduct regular reviews and assessments of quality systems to identify areas for improvement.
- Collaborate with Quality excellence team in developing internal & corporate quality KPIs to assess the overall performance of the quality unit department (QA&QC) as a cross functional task with the quality excellence.
- Audits and Inspections:
- Assist in the preparation and execution of internal and external audits, ensuring readiness and thorough documentation.
- Collaborate with cross-functional teams to address audit findings and implement corrective and preventive actions.
- Documentation Management:
- Oversee the creation, review, and control of quality-related documents, including Standard Operating Procedures (SOPs), batch records, and validation protocols.
- Ensure documentation aligns with regulatory requirements and internal standards.
- Deviation Management:
- Lead and support investigations into deviations and non-conformances, collaborating with teams to identify root causes and implement corrective actions.
- Ensure timely and thorough documentation of deviation investigations.
- Change Control Management:
- Participate in change control processes, assessing the impact of proposed changes on quality systems and ensuring appropriate documentation.
- Facilitate effective communication and collaboration during change control activities.
- Training and Education:
- Contribute to the development and delivery of training programs related to quality compliance and regulatory requirements.
- Provide guidance to personnel on compliance-related matters.
Whatever your area of expertise, your work within the Servier Group helps advance therapeutic progress for the benefit of patients. You will be part of teams recognized for their scientific excellence and reach your full potential in a professional environment that encourages you to develop yourself. Tailor-made onboarding journeys, mobility opportunities, quality trainings, responsible management, team spirit... All this and more in a workplace focused on your well-being.
At Servier, we are committed to therapeutic progress to serve patient needs. We put the diversity of our employees as a source of richness for the fulfillment of this vocation.