The Plant Lead Quality will oversee the Quality Assurance (QA) and Quality Control (QC) functions ensuring compliance with global regulatory standards continuous process improvement and effective SAP integration. The role is critical to maintaining high-quality manufacturing standards and supporting the facilitys global operational goals.
Develop implement and maintain QA policies and procedures to ensure compliance with pharmaceutical regulations industry standards and internal requirements.
Lead and mentor QA/QC teams to foster effective quality management practices.
Monitor key quality metrics and implement corrective and preventive actions to resolve issues and drive continuous improvement.
Lead the implementation configuration and optimization of SAP Quality Management (QM) modules.
Collaborate with IT and SAP consultants to ensure SAP solutions align with QA requirements and regulatory compliance.
Train and support QA and production teams on SAP QM functionalities and best practices.
Prepare for conduct and oversee internal and external audits including regulatory inspections and certifications.
Resolve audit findings and implement corrective actions.
Keep up-to-date with audit requirements and industry standards.
Ensure QA processes comply with GMP FDA EMA and other relevant regulations.
Monitor changes in regulations and update QA processes accordingly.
Coordinate submissions and communications with regulatory bodies.
Identify and lead initiatives to enhance QA processes efficiency and product quality.
Implement best practices and continuous improvement methodologies within QA.
Analyze quality data and trends to support data-driven decision-making.
Oversee creation maintenance and review of QA documentation including SOPs validation protocols and quality reports.
Ensure timely and accurate reporting of quality performance to senior management.
Evaluate and monitor quality of materials and components from suppliers.
Collaborate with suppliers to resolve quality issues and improve supply chain standards.
Bachelors degree in Pharmaceutical Sciences Chemistry Biology or related field.
Advanced degree or professional certification (CQE Six Sigma) is a plus.
Minimum 10 years in pharmaceutical QA within a manufacturing environment.
Proven experience with SAP Quality Management (QM) implementation and optimization.
Extensive experience managing internal and external audits including global regulatory inspections (EMA USFDA MHRA).
Expertise in quality control techniques sampling inspection and testing.
In-depth knowledge of cGMP ICH WHO EMA USFDA and MHRA guidelines.
Experience with Quality Management Systems Risk Management Data Integrity and Industry 4.0 applications in QA/QMS.
Strong leadership communication and interpersonal skills.
Excellent analytical problem-solving and decision-making abilities.
Proficiency in SAP QM and related modules.
Ability to drive continuous improvement in complex QA processes.
Strategic thinking with a results-driven mindset.
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