Manager, Regulatory Affairs and Quality Assurance
Hikma Pharma, APIs Division
مجموع سنوات الخبرة :21 years, 6 أشهر
Designed and implemented sustainable, cost-effective system of Quality Management associated with the Business Continuity Planning at Hikma APIs plant, including CGMP, Documentation, environmental and occupational operations related to highly potent, oncology drug substances technology which is one of the kind in Middle East.
Managed RA & QA employee, Recruiting and induction as per Human Resource Policies, Quality Management System and Quality Tools with increasing regulatory requirements. Supported Product Quality and marketing strategy by timely, scheduling, documenting and closure of variances & Customer Complaints in addition to periodic check-ups.
Improved Quality knowledge and regulatory intelligence to exceed key performance indicators. Advice, create/modify policies and procedures, referring to publication and using effective coaching and counseling.
Saved the over-cost and worries about cross contamination by establishing new scientific, risk-based approach of cleaning validation acceptance criteria in addition to incident management contributions. Also observe engineering works and process improvement with systematic verification to meet product specifications by less cost and time.
Increased the annual target of submitted Drug Master Files (DMFs) in CTD format to US and Europe by 30%. Maintained other old DMFs through systematic Annual Amendments and coordination with ANDA / MA holders and other government interactions.
Conducted regulatory, compliance Audits / inspections on multiple contract vendor manufacturing sites. Advised with regulatory intelligence toward supporting approval after reviewing scientific and administrative content of registration files.
Maintained all previously submitted DMFs by handling Deficiency letters and Regulatory Information Requests to achieve stable status with “No-more Comments” or “Approval” by regulatory agencies.
Significantly reduced time of DMF preparations at Regulatory Affairs Department and so increased the outcome by distribution of regulatory knowledge and well sequenced plans to other departments.
Established periodical review system to be up-to-date with main international standard of pharmaceutical regulations (FDA & EMA) in addition to MENA and Local Jordan FDA requirements.
Contributed and designed solutions for many ad-hoc cases within the organizational projects in Synchronize with R&D.
Built an enterprise of integrating documentation and data security for Analytical output of Quality Control Testing.
Developed a well-trained team to technically and administratively performing their job roles and being comply with GLPs and regulations.
Composed a network of advanced instruments with high value-against-cost qualified for Quality Control technical testing.
Developed excellence in the advanced up-to-date technology of Drug Substance as well as Finished drug dosage form analytical testing, development and validation.