Quality assurance o quality control manager o manager qualità

In this company, producing API’s by chemical synthesis, I’m responsible for the Quality Unit including Quality Control, Quality Assurance and Regulatory Affairs, and the Qualified Person of the site, in charge for lot release. My main objectives for the first year have been to coach the new staff in the Quality Unit, expand the Quality Control Lab and introduce the use of the ERP system to cover the GMP related activities, preparing the system for the validation. 
Staff supervised : 4 people in QA,  8 people in QC, 1 in RA.
I report into the CEO.

Quality Control Manager in a FDA approved high potency API manufacturing plant. I am responsible for all the QC activities in the plant managing 30 people operating in different shifts in the Chemical and Microbial Laboratories. I report into the Corporate Director of Operation. The QC department processes a very large number of samples a year from raw material to in-process control and finished product testing, provides strong support to the regulatory affairs and the business units in terms of non-routine testing and analytical method validation. 

The site producing Active Pharmaceutical Ingredients, High Potency Drugs and Nutraceuticals is FDA approved. My responsibilities embrace Quality Assurance and Quality Control, managing all the activieties required by cGMP and ICH for the manufacture of APIs. Domestic ANVISA inspection and FDA inspection were hosted.
Staff supervised : 6 people in QA, 14 people in QC.
I report into the Corporate Quality Director.

In this site dedicated to Active Pharmaceutical Ingredients manufacturing (FDA Approved) I am responsible for the analysis of Raw Materials, intermediates, finished products, and for the analyses to support Production and Quality Assurance. I maintain the analytical methods in conformance to the applicable Pharmacopoeias and Drug Master Files.
I am responsible to set up and validate analytical methods, to maintain the stability program and the equipment to be efficient and up-to-date; I handle analytical personnel training. The instrumental analyses are performed by means of HPLC, GC, FTIR, UV-vis, Automatic Titrators (Potentiometriand Karl Fischer), Laser Particle Sizers, Differential Scanning Calorimetry, Polarimetry. 
I am responsible to prepare and maintain the Quality Control budget. 
Staff supervised : 14 people in QC.
I report into the Plant Director.

Farchemia is a company manufacturing Active Pharmaceutical Ingredients, FDA approved, ISO 9001 and ISO14001 certified,  subsidiary of the multinational company Tessenderlo; I am Quality Assurance & Regulatory Affairs Manager and Quality Control Manager (Quality Unit). I am responsible for the Quality budget and participate to the Site expenditure budget definition to maintain and improve the compliance to GMP and customer’s requirements.  
Staff supervised : 7 people in QA,  14 people in QC, 1 in RA. I report into the CEO.
In this company I coordinate the Quality System assuring the application of GMP, ISO 9001 (Management Representative) and the management by processes. 
I am responsible to manage the lot release activities supporting the Qualified Person, I host regulatory inspections (AIFA, FDA, KFDA) and the frequent audits from customers; I audit raw material and service suppliers, I prepare or review Technical Agreements, I coordinate the internal audit team. 
I have worked closely with Engineering and a contractor in a project for the Finishing Department revamping (definition of User Requirements and Qualification of the systems) aimed to full alignment to GMP requirements.
Other activities of my function were the management of the Stability Program, analytical method validation, changes, Drug Master Files; I coordinated the process validation and training activities, the investigation of non-conformances, deviations and claims,   
I was Project Leader for the SAP validation. The project was successfully completed according to schedule.

I am responsible of the site compliance, the chemical and microbiological laboratories, the supplier qualification program and the definition of quality agreements, the management of material status and product release, the maintenance of manufacturing processes, the analytical method and process validation. 
I maintain relationships with colleagues from the Italian and foreign affiliates for Quality and Regulatory Affairs.
In this company I gained a solid experience in  food GMP and HACCP through frequent international liaison with colleagues from company affiliates, sharing ideas, projects and best practices. 
I was qualified Corporate Quality Assurance Site Quality Auditor by Warner Lambert / Pfizer and Quality Systems Internal Assessor by AICQ. I conducted quality audits in Italy and Europe on behalf of the Corporate Quality Audit department.  
I was project Leader for ISO 9001:2000 and MRP II class A certifications, both successfully obtained within schedule. The site was also ISO 14001 e OHSAS 18001 certified

In this company, ISO 9002 e MRP II class A certified, I maintain and improve manufacturing processes by means of continuous monitoring based on statistical techniques, pilot and industrial scale tests; I run the quality control of raw materials, work-in-process and finished products supervising the activities of the chemical control laboratory (main instrumental techniques : ICP-OES, AA, XRF) e and physico-chemical laboratory (B.E.T surface area, metal surface area, catalytical activity, laser particle sizing). I maintain technical relationships with customers, supporting the commercial function, suppliers and external auditors. 
I was able to design a new quality module of the information system, to improve some manufacturing and refining process yields, to establish a more stable product quality, to recover an important customer lost. 

I set up the chemical laboratory of the new plant and installed all new instruments (ion chromatograph, GC-MS, ICP-MS, Atomic Absorption flame & furnace, UV-vis spectrophotometer, ion selective potentiometres, autotitrators, particle counters for liquids and gases).
I developed analytical methods and control procedures for trace analysis in high purity chemicals and process materials; I qualified distribution lines of bulk chemicals, approved suppliers of process materials and services by means of chemical testing and audits. 
In Texas Instruments I had the chance to get experienced in process control techniques, to understand the Total Quality tools, to achieve a fluent English (one year stay in the U.S.A.).

I was involved in a innovation project to decrease the inclusion level of steel via filtration on oxide slags. My responsibility was to organise and conduct pilot plant trials. I executed viscosity test of slags in the range 1200-1500°C, the study of flow patterns of molten steel in the ladle via cold models and computer models. This experience enabled me to boost my computer skills.

I managed the chemical and microbiological laboratories to test and release raw materials, semi-finished and finished products (injectable antibiotics, capsules, tablets, creams and suppositories) and maintanied the statistical process control data.

Indirizzo Analitico / Chimico Fisico