Dr. Anita Milicic-Tang

December 2019

– to date

Senior QA Compliance Manager GMP/GDP Idorsia Pharmaceuticals Ltd., Allschwil, Switzerland

• Coordinate and conduct GMP / GDP audits and self-inspections; write
  corresponding audit reports
• Report critical self-inspection findings to the Responsible Person and
  management
• Coordinate, plan and manage Regulatory Agency Inspections
• Support preparation of Regulatory Agency Inspections
• Notify management of potential quality and regulatory issues
• Ensure GMP compliance of the external and internal facilities, utilities,
  systems and equipment with coaching
• Manage, review and approve change controls, deviations and CAPAs
  related to the internal pharmaceutical operations facilities (not project
  specific) with coaching
• Manage, review and approve of qualification & validation documents of
  GMP equipment (facilities and utilities)
• Write, review, and/or approve internal quality system SOPs and other
  GMP/GDP and regulatory related documentation with coaching
• Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement (QS document including Quality agreements with third parties)
• Administer systems to monitor (KPIs), track, and trend regulatory compliance (e.g. deviations, CAPA, investigations, complain, change control etc.)
• Manage filing process and system for all quality documents
• Administer system for e-documentation (Idorsia EDMS)
• Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant

November 2017

– November 2019

Novartis Unified Quality Audit Program (UQAP) Manager
Novartis International AG, Basel, Switzerland

• Develop and maintain the Novartis Unified Quality Audit Program
  (UQAP).
• Provide oversight of UQAP audit plan across Global organisations
  through appropriate metrics and analysis
• Support risk assessment calculations.
• Prepare standard operating procedures for the UQAP process.

September 2012
– October 2017

Senior GMP Auditor, Novartis Technical Operations (NTO) Quality Novartis Pharma AG, Basel, Switzerland

• Plan and perform GMP audits according to Novartis unified quality
  audit program (about 25 audits per year as Lead Auditor). Audits
  include Novartis country affiliates, suppliers / contractors for API and
  finished dosage forms, warehouses and distribution centres, different
  service providers etc. Evaluation of provided CAPA plans.
• Conducting of pre-approval or “mock” pre-approval inspections at
  contractor/supplier level.
• Supporting HA commitments and global commitments / initiatives of
  inspection findings (for example performing Complaint Handling
  Assessments at various sites).
• Support compliances activities in collaboration with Compliance group.
• Support auditors training and certification process and perform in field assessments for auditor certification.
• Act as a contact person for onboarding of new auditors.

2005 – 2010

Compliance Manager Supplier Relations, Novartis Pharma,
Chemical Operations Switzerland, QA Compliance, Novartis Pharma AG, Basel, Switzerland

• Led Chemical Operations internal inspections in Switzerland, Ireland and China. Championed revision of testing monograph, deviation/OOS handling processes. Reviewed a range of ChemOps SOPs. Drove preparation of training curriculum and conducted training programs for China ChemOps QA & Sourcing for auditing and supplier qualification (including databases).
• Led API supplier audits (ca 50 audits, > 20 in China. Performed
  Supplier qualification. Established global ChemOps supplier
  qualification and auditing data bases (SUQUOR and SAIS, replaced by Trackwise).
• Facilitator for HA authority inspections (USFDA, KFDA, PMDA,
  Swiss HA) of NVS ChemOps sites.
• Project leader of the ChemOps CH IQP project „Supplier
  audits“ enabled more efficient and productive supplier approval process at the Purchasing- ChemOps interface.
• Acted as a deputy of the Team Head, facilitated operational business aspects of 7 associates.

2002 – 2005

Release Officer, Chemical Operations Switzerland QA Compliance Novartis Pharma AG, Basel, Switzerland

• Responsible for release of APIs and intermediates.
• Deviation handling; Writing of Annual Product Reviews; Change
  control
• Performing supplier audits.
• Participation to authority and customer inspections.

2000 – 2002

Manager Quality System, Siegfried Ltd., Zofingen, Switzerland

• Accountable for GMP quality assurance for chemical and
  pharmaceutical production
• Performing of supplier and internal audits
• Responsible for GMP training for Siegfried Ltd.
• Organizing of authority and customer audits.
• Documentation management

1995 – 1999

Chemist, Laboratoire Pont Saint-Germain, Porrentruy, Switzerland

• Head of Quality Control
• Head of ICP (Inductively Coupled Plasma Spectroscopy) laboratory
• Responsible for elementary analysis
• Research in the field of industrial materials

1989 – 1993

 First Assistant, Université de Lausanne, Groupe Prof. J-C. Bünzli

• Research in the field of inorganic and analytical chemistry by using FTIR, Raman, UV-VIS, NMR and EPR techniques
• Responsible of the FT-IR / Raman laboratory
• Providing training and laboratory practice for students