Highlights:Pharmaceutical industry

Skills:Pharmaceutical Quality Assurance, Pharmaceutical quality assurance

Goal:Pharmaceutical Quality Management

Membership:Highly experienced

Certification:Highly experienced

Honor:Working with multi national companies

Quality Assurance Manager 09/2013 - current
Darousazi Behestan, Kaveh industrial city , Markazi Iran
Industry: Pharmaceutical
Managing or supporting all quality issues
Managing or supporting all quality issues with risk management approach including: complaints, deviations, OOX, change control, risk evaluation committee, Management Review, recalls, returns, supplier evaluation, product tampering, stability failures and any regulatory non-compliance identified, as applicable. Ensuring investigations are correctly executed and all required actions are taken appropriately and in a timely fashion. ? Oversight of cGMP quality assurance activities and requirements in all relevant departments, and for drug substances, intermediates and in- process and finished drug products. ? Responsible for the QA batch record review to ensure all materials meet regulatory and product specifications. ? Assessing quality trends including stability reports and annual product quality reviews in a timely manner as per local and global procedures and driving continuous improvement opportunities. ? Review and approve documents related to QA, production, engineering, warehouse, and other departments. ? Support, planning and execution of the validations, qualifications and calibrations. Review and approval of protocol/ reports regarding equipment qualification, process/system validation and continued process verification. ? Leading the external supplier qualification process including supplier quality risk assessment and preparation and review of quality agreement based on regulatory requirements.--

Azad University 09/2003 - 02/2007
, , Iran
Degree: Bachelor's Degree
Major:Applied chemistry
Bachelor of applied chemistry

Hassan Soltandoust Resume Resume