Quality Assurance Manager
NATpack
مجموع سنوات الخبرة :9 years, 8 أشهر
•Ensures product compliance to the approved design & reference specifications required by the customer throughout 3 production shifts by daily controlled reporting system.
•Traces technical NCRs in production sites for leading the investigations & following up the initiated CAPAs plan with the concerned departments.
•Ensures the final product release upon completeness of all required actions (IPC, FP inspection, COA, dispatch inspection…).
•Ensures & maintains all communications required among QC, IPC, Production & QA members to stabilize all processes' parameters & specifications.
•Leads the investigations of customer complaints in close coordination with QA members, Technical Operations Manager & other concerned departments heads to take the appropriate CAPAs plan in the most appropriate time.
•Handles & manages all customer's & third parties' audits.
•Passing surveillance audits for ISO17025/2005 & ISO 9001/2008 for 2015 & 2016 respectively.
•Follow up internal auditing & site inspection findings & appropriate CAPAs progress.
•Reporting all audits' findings, action plans & areas for improvement to the Managing Director.
•Conducts interviews with the new applicants for staffing & maintaining the department manpower.
•Did the performance appraisal for the department members (year 2015 & Q1-2016)
•Beginning establishment of new documentation system with regard to cGMP & regulatory authorities' guidelines (BPR, SOPs, Checklists…. etc.).
•Applying an IPC procedure in production areas to implement double check & approval system throughout all product stages.
•Reviews & ensures compliance to cGMP in the whole site (M/C qualification, Calibration, Clean Areas' Validation, and Process Validation).
•Reviewing & updating WH procedures for incoming materials' receiving, storage & release.
•Ensures & traces the implementation of deviations, NCRs & CAPAs management procedures in the site.
•Final approval for finished products' release upon reviewing compliance & completeness of all required actions & documents.
•Conducts training for all the concerned departments on cGMP, newly issued SOPs and products' Batch Production Records.
•Conducts on job training for QA Specialists on IPC, GSP, GLP, internal auditing & self inspection.
•Passing MOH site audit for license of Liquid Dosage Form production line.
- Monitoring and supervision of all Quality Assurance activities in the plant (IPC, Batch record review, Validation, Auditing, Documentation, etc.).
- Ensuring the effectiveness of Quality Assurance monitoring for the whole production process that meet quality standards specified.
- Process verification and SOPs writing for the technical departments of the plant.
- Conduct planned and unplanned internal audits as a member of the internal audit team.
- Interact with departments' Section Heads and Supervisors to co-ordinate different activities affecting the process quality.
- Ensuring, with all QA Specialist, the compliance of cGMP in all processes carried out.
- Ensuring QMS effectiveness & compliance with ISO 9001\2008 with regard to Alandalous quality policy.
- Assist & contribute in passing all site inspection audits (all external and regulatory audits).
- Assessment and reporting hazardous & unsafe situations in areas related to production process.
- Ensuring & implementation of CAPA system effectiveness with regard to NCRs initiated and Management review meetings.
Inspection of manufacturing operations to ensure compliance with cGMP and other regulatory requirements. Participating in process validation & cleaning validation in production areas. Validation for new production areas & following the different qualification stages (IQ, OQ.& PQ) of new production machines. Checks and co-ordinates quality requirements among production and other departments. Assist in regulatory inspections. Reviewing deviations & investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented. Training & evaluation of QA Specialists. Reporting to QA & QC Manager.
IPC inspection in Liquid and Semisolid dosage forms. Transferred, by election, to Solid dosage form IPC team. Random check test throughout processes for critical start up tests. Reviewing batches’ records for completeness, correctness and compliance to in-process control results with specification and reporting of unusual incidents. Using spectrophotometric methods, colourimetric methods and other analytical methods for active material detection between different products. Reporting data for all processes carried out. Reporting to QA Supervisor and to QA & QC Manager.
Sampling and IPC inspection for raw materials, packaging materials, intermediates and final products.
Carryring out required Chemical and physical analysis for intermediates and finished products.
Reporting to the plant technical manager.
Blood sampling and Preparation of samples for analysis.
Preparation of different Reagents and Chemical solutins.
Carrying out required chemical tests for analysis, Microscopical examinations and Reporting results.
ACADEMIC COURSES Organic Chemistry Analytical Chemistry. Physical Chemistry. Inorganic Chemistry. Chromatography. Spectroscopy. Potentiometry. Instrumental Chemistry. Physiology. Histology and Histochemistry. Parasitologty. Microtechniques. Genetics and genetic engineering.