Annamaria Paparella

rriculum Vitae - Annamaria Paparella   

First Name:

Annamaria

Last name:

Paparella 

Address

Via degli Adimari 98-00148 Rome

 Contact e-mail

paparella.a@libero.it

Mobile Phone:

+39 348 3976027

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Work experience

Date to-from:June 2015-to date - Takeda Italia SpA

Current Takeda Job Title: LOC Quality Head responsible for the quality management system for all GxP areas  (commercial & R&D) – coordination of  a team composed of 6 people

Main role objectives

• Responsible for leading the Quality Management System at the Italian Affiliate
• Single point of contact for Quality aspects in the affiliate
• Leading the Affiliate Quality Councils
• Collaborates with the affiliate Leadership to achieve Business objectives
• Aligns with the Leadership on people selection and Budget (in the QA field) - conducts performance management & development of Quality people

Main Accountabilities

-Manage GxP-regulated activities in the affiliate to ensure compliance to Company requirements & local regulations, and the supply of quality & compliant products to patients in a timely manner

-Implement Company QMS in order to ensure ongoing compliance to the quality standards and procedures at the affiliate. These include but are not limited to: change control, deviation, CAPA management, training, document management, complaint handling, etc.

-Develop and execute Annual Country Quality Plan.

-Establish and maintain the local risk register and risk strategy for GxP areas

-Ensure local Quality Council / Management Review is conducted on a regular basis. .

- Monitor key performance indicators, evaluates and highlights any significant trends and identifies actions.

-Drive and strengthen the Quality Culture at the affiliate

-Gather local regulatory & quality intelligence. To communicate and raise awareness of upcoming and new regulations within Takeda.

-Provide quality support for product launches

-Ensure responsibilities and duties of RP/QP are complied with

- ensure a system for collectiona and evaluation of product-related complaints in the Affiliate is in place

- ensure that appropriate CAPAs  system is in plece where, and verify its effectiveness

-Initiate Notification to Management / escalation report for notifiable events Procedures.

- Execute local recall/market action o), and ensure timely completion of the required actions

-Support health authority communications on Product Quality issues impacting the country

-Implement Supplier Quality Program at the affiliate using a lifecycle management approach

- Establish and maintain internal and external Quality Agreements.

-Ensure oversight of local GDP and GMP activities, e.g. local (re)labelling/(re)packaging, cold chain management, temperature excursion management, method transfers, etc.

 -Ensure  the batch releases &/or duty of care releases, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.

-ensure that PQRs are revised and in compliance to the requirements of the market

- Manage of all quality topics related to medical devices used with medicinal products concomitanlty

- Ensure that internal and external Quality Agreements are in place

- Ensure customer bona fide checks, to ensure the appropriate & valid authorizations and licenses are in-place.

- Establish and lead internal audit / self-assessment program at the affiliate, to evaluate compliance with product quality systems & processes and to identify improvement opportunities. 

- Lead regulatory inspections at for GMP/GDP/Product quality related activities/ GCP/PV  nd ensure that regulatory commitments are duly completed on time.

-Provide quality oversight of local GCP/GVP activities, e.g local studies, PV activities

Date from-to:June’12-June’15  Takeda Italia Farmaceutici

Job Title: Quality Assurance Manager, GDP Manager and Responsible for Scientific Service 

Date from-to:May’05 –May’12 Takeda Italia Farmaceutici

Job title:Quality Assurance Manager at Takeda Italia Farmaceutici

(Quality Areas: GCP, GMP/IMP, Pharmacovigilance, Regulatory Affairs and Medical

Documentation)and  Responsible for Scientific Service at Takeda Italia

Farmaceutici S.p.A –Rome

Date from-to :Mar‘98- Apr‘05 Takeda Italia Farmaceutici

Job Title: Quality Assurance & Safety Manager

(Quality Area: GCP)

As Safety Manager she is the company Responsible Person for all Pharmacovigilance activitiesby ensuring that the safety profile of all company products is properly monitored both in  pre and post authorization phases and the appropriate countermeasures are taken  in case of any change of risk/benefit assessment. She is responsible for reporting the safety information internally and towards the company group and the Health/Regulatory Authorities in strict compliance with the national legislation and the global and local procedures/guidelines on Pharmacovigilance

Date from-to:Sept ‘97 –Feb ‘98

Job Title: Quality Assurance Manager - Bioprogress S.p.a Anagni (Frosinone-Italy)

(Quality Area:GMP)

She ensures that the manufacturing of the medicinal products is conducted in compliance with GMP and applicable laws. The technical support to the elaboration of toll manufacturing agreements and the preparation of technical dossiers are also part of the activity

Date from-to:Jan ‘96 –Jul ‘97

Job Title: Clinical Project leader- Fidia Advanced Biopolymers ( Abano Terme- Padua- Italy)

Coordinatiom of clinical project on hyaluronic acid (project management, elaboration of clinical protocols, coordination of monitoring activities, etc)

Date from-to: Oct ‘94 –Dec ‘95

Job Title: Pre-manufacturing Specialist

Finalization of formulations of  hyaluronic acid in  Osteoarticular and  Plastic Surgery

Date to-from:Nov ‘91 –Mar ‘92

Job Title: Teacher of Physical Chemistry and Organic Chemistry at  Higher school “N. Chiarulli” – Bari

Education

Education

July 1991: Degree in Pharmaceutical Chemistry and Technology,

University of Bari - Italy

(Passing mark of 110/110 with honours)

Post Graduate 

Date to-from:Apr ‘92 –Sept ‘94

Post-graduate grant from Italian “University and Research” Ministry

Project Management on the “Chemistry and Technology of Biopolymers”

May‘94- Sept’94(Padova-Italy) Stage at Fidia

Advanced Biopolymers S.r.l. Drug release from hydrogels of hyaluronic acid

Jul‘92-Jul’93 (Pisa-Italy):Research Stage- Chemistry and Industrial

Chemistry Department of the University of Pisa (Tutor: Prof.Emo Chiellini). 

Microbic and enzymatic degradation of polymeric materials

Sept ’93-May ’94(West Lafayette-USA): Research Stage-

Department of Industrial and Physical Pharmacy-Purdue University,

West Lafayette, IN., USA (Tutor: Prof. Kinam Park). 

Synthesis and Characterization of polysaccarides hydrogels as systems for drugs release, enzymatic degradation of polymeric materials

Apr ’

92-Jul’92 (Brindisi-Italy):Training courses on Macromolecular

Chemistry and management aspects (Industrial manufacturing; quality aspects)

Professional Affiliations

 Professional Association

• Member of the thecnical board on counteracting pharmaceutical thefts group driven by the Italian Agency
• Member of Farmindustria (Italian Association of Italian Pharmaceutical Companies)Good Distribution Practices
• Member of AFI: Associazione Farmaceutici Industria
• Member of  SIMeF  (Società Italian di Medicina Farmaceutica)

Achievements/Honors

 2010 “Takeda Global Awards “ ; winn as best performance in the local affiliate

From 2018:Contract Professor at Torvergata University,  Rome- Biothecnology- Course title: Clinical Quality Data Management

-Teacher at  Master  “Quality System: GXP & ISO”, Università Cattolica del Sacro Cuore, Rome

-Speaker at many seminars on counterfeiting measures

Publications/Conference Presentations

Publications and patents

Together with the thecnical board on counteracting pharmaceutical thefts group driven by the Italian Agency, coauthor  of the  booklet Theft of medicines. update 2019

A. Paparella, K. Park,

“Synthesis of Polysaccharide Chemical Gels by gammma-Irradiation”

ACS Symposium Series, No: 620, Irradiation of Polymers(Ed. R. L. Clough and S. W. Shalaby), 1996,180-187

E. Chiellini, A. Corti, A. Giovannini, P. Narducci, A. Paparella, R. Solaro,

“Evaluation of Biodegradability of PCL/PET Blends",

Journal of Environmental Polymer degradation,Vol. 4, No 1, 1996,  37-50.           

Park K., Paparella A., Benedetti L.,

”Synthesis of chemical gels from polysaccharides”

Patent Application N° 96-03147

Bellini D., Paparella A., O’Regan M., Callegaro L.

“Pharmaceutical compositions containing auto-crosslinked acid and related

pharmaceutical compositions for the treatment or Arthropathies”

Patent Application WO97/49412           

Relevant Courses

 A significant list of courses attended-available upon request

Skills

 Very Good English skills

Strong leadership

Familiarity with industry standard computerized systems

 Very Good written and verbal  communication skills

Pesonal attributes:  Good relationship and interaction with company functions