Quality Vacancy At Servier Egypt
Senior Quality Compliance Specialist
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.
Profile description:
•Bachelor's degree in pharmacy or related field.
Advanced degree (MSc) is a plus.
Minimum of 3-5 years of experience in quality compliance within the pharmaceutical industry.
•Strong understanding of cGMP, WHO regulations, and industry standards.
•Excellent attention to detail, analytical skills, and problem-solving abilities.
• Effective communication and interpersonal skills.