QA Stability
Expert

Date: 06/06/2019
Ref: MK-HP4

Position in organization

  • Department: Quality Assurance (QA)
  • Reporting to: QA System Manager
  • LocalizaciónStaff in charge: –
  • Location: Esplugues de Llobregat

Education

  • Degree in life sciences, preferably in Pharmacy or Chemistry
  • Master’s degree in Analytical Control of Pharmaceutical Products
  • Very important to have excellent level of English and Spanish, spoken and written

Previous experience required

  • Stability regulation (ICH, EU, FDA) knowledge
  • Experience in finished product pharmaceuticals / APIs
  • Experience with analytical investigations, change control and documentation management
  • Minimum 3-5 years’ experience working in a laboratory/quality environment with excellent knowledge of cGMPs.
  • Experience MS Office
  • Minitab

Roles and responsibilities

  • Accountable for the design/development, implementation, ensuring compliance readiness and governance of stability programs for assigned commercial product(s).
  • Key contributor for developing consistent strategies for stability studies performed at different sites, CMOs and partners, ensuring compliant with cGMPs.
  • Start, manage and close stability studies for assigned commercial products as needed, timely and accurately to ensure the achievement of corporate goals and objectives.
  • Lead and assure adequate investigations for out-of-specifications (OOS), out-of-trends (OOT) and out-of-expectation (OOE) deviations. Operate CAPA/deviation, training and compliance systems.
  • Provide technical support and perform critical and scientifically sound data analysis, including statistical analysis (Minitab), for comparability studies, shelf life, degradation rates, trending and trend limits, specification changes, and impact analyses. Provide technical leadership in evaluation of generalized approaches for stability data evaluation.
  • Provide scientific and technical support of stability in all stability relevant sections for Regulatory Submissions, Regulatory Agency responses, and PQR.
  • Review and assure adequate Quality Technical Agreements with all GxP stability related vendors.
  • Keep updated on GMP regulations and evaluate the impact within our own Quality System and activities.

Skills

  • Motivated, disciplined, proactive, dynamic, methodical, organized and decisive
  • Self-sufficient
  • Strong analytical and problem solving skills
  • Excellent communication, planning and time management skills
  • Highly responsible and capable to work under pressure to meet deadlines
  • Ability to prioritize multiple tasks
  • Detail oriented and research skills
  • Capable of working under it´s own initiative whilst being a good team player

Apply now

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Thanks for your interest in Galenicum. We will get back to you if your profile is a match.

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