Dr. Bacel Mikhael Alasas, PhD

Collaborated with the General Manager to formulate strategic vision, long-term plans, and institutional policies, ensuring effective execution through continuous monitoring and implementation of corrective and preventive actions to achieve corporate objectives.

Led enterprise risk and opportunity management by systematically analyzing organizational context, stakeholder expectations, and operational processes, ensuring proactive adaptation to market dynamics and reinforcing organizational resilience and performance.

Exercised executive authority to issue administrative directives, optimize workflows, and enhance workplace efficiency, conducting daily operational inspections across all departments to monitor production adherence, quality compliance, and facility readiness.

Represented the company in official engagements, fostering strategic partnerships and upholding corporate interests.

Established, maintained, and continuously improved the IMS, ensuring full compliance with ISO 9001, 14001, 45001, GMP, and all applicable regulatory requirements.

Formulated strategic and operational policies with top management, proactively managing risks, opportunities, and stakeholder expectations.

Supervised QA and QC activities to ensure effective IMS application across quality, environmental, health, and safety domains.

Oversaw equipment qualification, process validation, and enforced RCA linked to a robust CAPA system to ensure sustainable root-cause solutions.

Made final batch release decisions by scrutinizing laboratory results, stability data, and compliance reports, safeguarding product quality and patient safety.

Designed and implemented internal audit programs, trained internal auditors, and coordinated with certification bodies for external audit readiness.

Monitored system performance via KPIs, identified improvement opportunities, managed institutional knowledge, and fostered a culture of innovation and continuous excellence.

Exercised delegated authority for critical decisions (e.g., production suspension or product recall) to ensure business continuity and personnel safety, reporting directly to the General Manager.

Delivered accredited Lead Auditor training programs for ISO 9001, ISO 14001, ISO 45001, AU, and TL, training over 100 professionals in advanced auditing techniques.

Assessed auditor competence through practical evaluation, examinations, and workplace assessments, ensuring the highest professional standards are met.

Mentored aspiring Lead Auditors in leadership, interviewing, evidence evaluation, and process-based auditing to drive continuous improvement.

Led audit teams for ISO 9001, 14001, 45001, and ISO 22000 for multiple clients, evaluating governance, leadership, compliance, and overall management system maturity.

Delivered comprehensive executive audit reports, providing clear identification of strengths, non-conformities, and strategic improvement opportunities to senior leadership.

Verified the effectiveness of CAPA and Root Cause Analysis (RCA) by evaluating objective evidence, ensuring sustainable corrective actions are implemented.

Led end-to-end implementation of IMS (ISO 9001, 14001, 45001, 22000, GMP) for numerous organizations, guiding them from initial gap analysis to successful ISO system certification.

Conducted strategic analysis (SWOT, PESTLE, Interested Parties Analysis) and process mapping to define organizational context and identify key business risks.

Implemented a risk-based thinking approach across client operations, resulting in the creation of comprehensive Risk Registers that proactively mitigated operational and compliance vulnerabilities.

Delivered postgraduate courses in Quality Management, IMS, and Operational Excellence, influencing the next generation of quality professionals.

Supervised postgraduate research in Six Sigma and organizational performance, fostering a research-driven approach to solving practical management problems.

Supported the University's ISO 9001 QMS by conducting internal audits and contributing to the documentation review process to maintain certification.

Performed analytical testing on raw materials, in-process samples, and finished products using HPLC, UV-Vis, FTIR, and Dissolution Testers, ensuring compliance with USP and BP standards.

Supported OOS investigations and deviation management, collaborating with QA and Production teams to implement effective CAPAs and improve manufacturing performance.