R & D Senior Supervisor
Pharma International
Total years of experience :7 years, 9 Months
8Year's experience in Pharmaceutical field.
• Joined ASIA pharmaceutical industries July 2005 - Mar 2013 (Aleppo - Syria) as R & D Senior Supervisor from Jan 2009 until Mar 2013: • Joined Pharma International (Nalchik - Russia)asR&D Senior Supervisor from April 2013 till present: KEY RESPONSIBILITIES AND TASKS: Establish work schedules and prioritize activities to meet company requirements.
Participate in Development, maintaining and improvement quality processes and systems in accordance with applicable global regulations and standards.
1. Conduct root cause analysis, as well as implementing corrective and preventative actions.
2. Conduct out of Specification (OOS) investigation.
3. Cooperate with R & D manager to provide direction for R & D team; recruit, develop and train talent as needed in support of the quality function objectives.
4. Ensure adequate training for all R & D staff.
5. Ensure that R & D systems and processes are complying with relevant cGMPs ISO (9001, 14000, & 18001) and Safety standards at all times.
6. To focus on performance efficiency within the R & D Department.
7. Assure accurate and timely completion of all tasks relating to the day to day activities.
8. Responsible for review and approval of all R&D documents (e.g. standard operating procedures system (SOPs)) to meet regulatory requirements.
9. Monitor R & D quality management system and maintain high analytical quality performance for the analysis of the new and marketed products to be in compliance with current (GMP/GLP)
10. Acting as Team leader for R & D external audits.
EDUCATION
Graduation: B. SC. From Faculty of Science- Applied Chemistry department, Aleppo University- May 2005.
SKILLS & TRAINING
Current Handling of Out of Specifications / Out of trend results (Jordan-October 2011-3 days).
Technical and regulatory challenges of validation (Damascus- August 2008, 3 days).
cGMP Implementation (ASIA Training center- Aleppo).
Internal Auditor (SGS).
PERSONAL TRAITS
Dynamic and hard-working professional with a background in Analytical R & D, detail-oriented and self-motivated.
PERSONAL DATA
Date of Birth: 29April1982.
Married: 2010.
Nationality: Jordian
Arabic : Mother Tongue
English : good
ACHIEVEMENTS
Development and validation of analytical method of about 350 drug products (New pipeline and market products).
Development and validation of analytical method dissolution of about 20 drug products (New pipeline and market products).
Reduce analytical method cost of Insulin injection - time reduction.
Reduce Calibration cost of HPLC.
Analytical method validation audit Compliance from pharmaceutical inspection co-operation scheme (PICS) on 2009.
REFERENCES
Furnished upon request.
Graduation: B. SC. From Faculty of Science- Applied Chemistry department, Aleppo University- May 2005.