Adecco Italia SpA, for an important Pharmaceutical Company, is looking for a
Senior Specialist, EQA Product Quality Manager (PQM) - Fully remote
The Product Quality Manager (PQM) is responsible for ensuring that all products managed by External Quality Assurance (EQA) are manufactured, packaged, analyzed, released, stored, and distributed in accordance with company expectations and all applicable regulatory requirements.
In this role you will have primary batch release responsibility and need to ensure that effective and robust Quality systems are in place to comply with required regulations, policies and guidelines governing the External Party manufacture and release of (API intermediates, API, non-sterile pharmaceuticals, sterile pharmaceuticals) by means of risk-based quality oversight and on-site supervision, as appropriate.
• Degree in Science, Engineering or any relevant technical discipline (BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent preferred).
• Previous experience in the Pharmaceutical/Biotechnology industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements. Previous experience in sterile manufacturing/assurance is a plus
• Accountable for a medium sized project with minimal resource requirements, risk and/or complexity
• Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills
• Communicates easily in English both verbally and in writing
• Strong knowledge of External Manufacturing management, supply chain, and operations
• Lean Six Sigma Systems training an advantage
Contract: 9 months.
Salary: Commensurate with seniority.
• Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations; review and approve changes to master batch records
• Manage routine and complex deviations and complaints, and assist in the coordination of significant investigations including Fact Findings; assist in the coordination of any product recall involving the external manufacturer
• Provide support for audits of External Party by internal audit teams and regulatory agencies; review audit outcomes pertaining to external manufacturers and ensure appropriate and timely corrective actions are implemented
• Oversee repackaging activities in the External Party
• Conduct routine and solves complex analytical change requests and support process modification change controls
• Stability Program management, including review of stability reports, and Annual Product Review assembly
• Provide on-site guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements
• Track and monitor operational and quality performance of the external manufacturer/partner and work with supplier to develop CAPA plans
• Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration; responsible for shipment under quarantine
• Support routine process validation; review and approve validation reports/tech transfer
• Prepare pre-PAI assessments; support document requests for regulatory filings and post approval changes
Categoria Professionale: Scientifico / Farmaceutico
Settore: INDUSTRIA CHIMICA/ CHIMICA-FARMACEUTICA
Città: Roma (Roma)
- Quality Assurance Manager settore farmaceutico - 24 mesi
- Quality Assurance Specialist - 24 mesi
- Laurea Magistrale
- Parlato: Ottimo
- Scritto: Ottimo
- Comprensione: Ottimo
- Word Processor - Elaborazione testi - Word, livello Ottimo
- Fogli di calcolo / elettronici - Excel, livello Ottimo
- Posta elettronica/Messaggistica - Outlook, livello Ottimo
- Sistemi Operativi - Windows XP, livello Ottimo
- Farmaco-Scientifico - Farmaceutica, livello Ottimo
- Farmaco-Scientifico - Tecnologie farmaceutiche, livello Ottimo
- Full Time