Daniela Pagani

CEO

Milan, Lombardy, Italy23 yrs 3 mos experience

Most Likely To SwitchHighly Stable

Key Highlights

Over 15 years of experience in QA and QC.
Expert in GMP and ISO9001 auditing.
Proven track record in managing quality systems.

Stackforce AI infers this person is a Quality Assurance expert in the Pharmaceutical industry.

Contact

Skills

Core Skills

Quality AssuranceQuality ControlAnalytical Chemistry

Other Skills

Quality Unit HeadQualified PersonQuality Assurance ManagerQualified Person eligibilityQuality System ManagementBatch ReleaseDeviations HandlingCAPAChange ControlInternal AuditsExternal AuditsProcess ValidationCleaning ValidationQuality Technical AgreementGMP Training

About

Qualified Person & Quality Unit Head More than fifteen years of experience in QA and QC in multinational pharmaceutical Companies. GMP and ISO9001 Auditor.

Experience

23 yrs 3 mos

Total Experience

5 yrs 9 mos

Average Tenure

6 yrs 9 mos

Current Experience

Archimica a brand of euticals s.p.a

Quality Unit Head & Qualified Person

Sep 2019 – Present · 6 yrs 9 mos · Lodi, Lombardia, Italia

Quality Unit HeadQualified PersonQuality AssuranceQuality Control

Amri (albany molecular research inc.)

2 roles

Quality Unit Head & Qualified Person

Promoted

Jan 2019 – Aug 2019 · 7 mos · Lodi, Italia

Quality Unit HeadQualified PersonQuality AssuranceQuality Control

Quality Assurance Manager

Nov 2017 – Dec 2018 · 1 yr 1 mo · Lodi, Italia

Quality Assurance Manager.
Qualified Person eligibility.
Responsible for managing and improving the Quality System of the Site. Main Topics: batch release, handling of deviations and CAPA, change control, internal and external audits, process and cleaning validations, Quality Technical Agreement, GMP training, KPIs, Data Integrity

Quality Assurance ManagerQualified Person eligibilityQuality System ManagementBatch ReleaseDeviations HandlingCAPA+11

Bayer

3 roles

GMP Compliance Head

Promoted

Jul 2016 – Nov 2017 · 1 yr 4 mos

Main topics:
Batch release activities in SAP P2R
Batch Record review;
deviations and CAPA handling;
complaints from the market handling;
internal GMP and ISO 9001 audits;
GMP and ISO 9001 external audits to suppliers and third parties
SOPs and GMP /ISO training
PQRs of finished products, raw materials

Batch ReleaseSAP P2RBatch Record ReviewDeviations HandlingCAPA HandlingMarket Complaints Handling+8

Chemical Laboratory Head

Jun 2012 – Jun 2016 · 4 yrs

Analytical release of excipients, APIs, bulk and finished drug products (chemical and physical analysis);
creation and update of TRDs;
internal and external audits;
lab to lab transfers;
calibration and maintance activities of the lab;
SOPs and training

Analytical ReleaseExcipientsAPIsBulk ProductsFinished Drug ProductsChemical Analysis+9