Qualified Person / Manager – responsible for a team of about 15 people (team under recruitment): Qualified Persons, Quality Operations Expert Associates (release), Quality Operations specialists; reporting to Quality Head. Responsible for two main activities: • Batch certification • Handling of deviations, nonconformities, products quality complaints, recalls, OOS/OOT/LE and all involved investigations, quality compliance on the shopfloorThe main responsibilities are including:- Acts as Qualified Person according to the legal requirements for importing activity of bulk products and finished dosage forms product and batch certification of the finished products packed in Turda / imported- Batch release of the investigational medicinal product- Responsible for issuing / approval of QP declarations- Reviews the documentation and checks that each product batch is manufactured and tested according to MA, national and international regulations, GMP and Stada policies- Takes decision ref. to status of PM and bulk products batches, in case of complaints to the suppliers and for the FG- Participates in the elaboration of the documentation for obtaining or extending the manufacturing authorizations and GMP certification.- Contact person for the competent authority.- Supervises the recall of medicinal products from the market and informs the competent authorities regarding the quality issues- Coordinates the investigations coming from deviations, quality nonconformities and market complaints recorded for released products- Verifies that OOS, OOT, other quality nonconformities are properly recorded and investigated according to GMP and approved SOPs- Monitors CAPA implementation- Reviews and approves the PQR- Reviews and approves the change controls and variations management- Involves in the review of Quality Technical Agreement (QTA)- Participate in the Self-Inspection and external audits (if the case)- External audits & inspection readiness support

Qualified Person/ Quality Assurance Department - responsible for a team of 2 qualified persons, 1 person handling the quality complaints and 5 persons working as IPQA shop floor.The main responsibilities include:- batch certification and batch release of: products (solid and sterile products) manufactured by Terapia for domestic and export markets; products manufactured by other countries and imported for EU markets and Investigational Medicinal Products - performs specific batch release activities in electronic systems (SAP, Tracelink – export of serialized batches into the EU hub, RfXcel – export of serialized batches for Russia market)- contact person for Regulatory bodies- informs the Regulatory bodies about the quality defects according to the regulations- in charge with products recall monitoring, handling and investigation of products quality complaints- approves the change controls and variations management- approves the Products Quality Review reports- performs QA review for deviations and CAPA; involvement in deviations investigation- reviews the Quality agreements as part of technical contracts- involvement in self-inspections and external audits to the suppliers- review the implementation of manufacturing recipe and manufacturing instructions according to the approved marketing authorization - approves the master of batch manufacturing records- approves the validation documents and all SOPs for manufacturing activitiesSelected accomplishments:- gives the necessary training for two qualified person, one person for complaints handling,IPQA shopfloor personnel ref. to manufacturing of OSD and sterile products; connections with information required to be checked in the batch manufacturing records- revision and implementation of SOP ref. to AQL (acceptance quality level) for OSD and sterile products- revision of SOPs ref. to qualified persons activities- arranging the new office for QP team- improvement of the communication within the team

PlantExtrakt is a Pharmaceutical Company, GMP certified, specialized in manufacturing herbal extracts as nutritional products (tinctures, glycerol macerates) and homeopathic drugs, having a large portfolio of SKUs for domestic and export markets (about 150 SKUs of nutritional supplements, 500 SKUs of tinctures for export, about 3,000 SKUs for homeopatic drugs). The Company is the first / single in Romania for manufacturing of homeopathic drugs. Responsible for manufacturing activity and a team of 50 people organized in the following departments:- Production planning and monitoring- Agriculture (in house organic cultures and harvesting the medicinal plants from wild flora)- Vegetable and Animal extracts (bulk, GMP certified)- Primary and secondary packaging of herbal extracts (nutritional products)- Homeopathic drugs (GMP certified)Responsible for all activities that involves operations: manufacturing, production facilities, production equipment, investment plan, revenue budget, compliance with GMP and procedures, quality system implementation, personnel and personnel development, documentation, maintenance and monitoring of environmental conditions, safety and staff protection. Selected accomplishments:- first monthly monitoring report of all manufacturing activities in order to give visibility to management- improvement of the planning process- improvement of the supply chain process- meeting the delivery terms for domestic and export markets- involvement in building the first revenue budget and CAPEX; montly report for status of CAPEX projects (all projects from the Company)- in charge with all projects for Production Department- improving the communication between the Company functions- training and coaching given to the subordinated team- recruitment and necessary training given to the New Production Director so she could fully act immediately after my leaving; there was no any gap in the activity caused by my leaving.

Experienced manager responsible for: (1) manufacture of solid oral dosage forms products (1 manager, 11 supervisors and 110 operators, approximately 85 products with valid MA in the current production); (2) manufacture of sterile products (1 manager, 5 supervisors and 35 operators, approximately 20 products with valid MA in the current production); (3) partial manufacture of IMP (preparation of test product and reference product for administration to volunteers during BQ studies); (4) development of packaging materials for production (2 supervisors) - design changes of AWs in order to implement all changes approved through variations. Responsible for all activities that involves operations: manufacturing, production facilities, production equipment, compliance with GMP and procedures, quality system implementation, personnel and personnel development, documentation, maintenance and monitoring of environmental conditions, safety and staff protection. Responsible for the implementation, monitoring and evaluation of performance indicators for operations; evaluation of quality matrix. Responsible for preparing and evaluating the revenue and expenditure budget; responsible for proposing the investment objectives (CAPEX). Selected accomplishments:- Participation on a team responsible for serialization project implementation- Implemented electronic systems, including: SAP, Electronic Document Management System (SOPs) and Trackwise; implementation of ISO certification for EHS system- Participated on a team responsible for the cGMP up-gradation of production facilities from inception to completion- Helped design URS and commissioning of equipment, including: blender, coating equipment, autoclave, automatic ampoules inspection machine, ampoules leak detection machine- Key person in several audits and regulatory inspections- People development – mentoring and coaching of young generation of chemical engineer and pharmacist

Manager responsible for the following activities:- qualification of equipment and systems- development of generic products / technology transfer projects- testing and analytical methods development for new generic products- process optimization and validation of the products from the current productionCoordinated team: 2 managers, 20 chemical engineers, pharmacists and technical engineers and 5 operators.The main activity was the integration into the Ranbaxy system and coordination of the technology transfer projects (manufacturing site change – from Ranbaxy India to Terapia), including both sterile and solid oral dosage forms products with direct involvement and coordination of 4 projects (sterile products).Involvement in the greenfield project for a new development facility in line with cGMP requirements. The project was stopped at the final stage before the installation of the equipment and then the location was modified to become the Clinical Unit of the Department of Pharmacology and Pharmacokinetic.

Interim activity for 6 months (to cover the temporary missing of the manager; the main activity was Manager of Research and Pilot Station). Responsible for managing a team of 6 people, consisting of pharmacists, engineers, chemist engineers and assistant. The main activity was:- optimizing the manufacturing process for current manufactured products in order to reduce / eliminate the process deviations- introduction in the current production of newly approved generic products; validation of the technological process- qualification of equipment and systems- implementation of the change control concept

Manager who led a team of 6 pharmacies and 4 operators. The main activity was the development of generic products (both OSD products and sterile products):- formulation, development of the manufacturing process- scale-up process- manufacture of the IMP- preparation of the necessary documentation for the product registration- optimization of the process on the industrial scale.One of the important achievement was to implement the quality system in an area that was outside it (way of working, SOPs, equipment qualification, cleaning validation, internal audit).Many of the products from the current production portfolio were developed as generic products at that time (more than 10 products).