Quality Specialist

vor 1 Tag

Basel, Basel-Stadt, Schweiz CTC Resourcing Solutions Vollzeit

Quality Specialist (Batch Record Reviewer) – 6792 ADA

Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a world-leading pipeline in Neuroscience and Dermatology with one of the strongest pipelines of Phase II/III studies in the world.

We are currently looking for a
Quality Specialist (Batch Record Reviewer)
for a
6 months' contract
(which can be
extended
), based in
Basel, Switzerland.

Role purpose:

Standard activities or routine tasks e.g.
batch records reviewer
, etc. Supportive
project work
. Support the
timely release of GMP relevant documents and batches
. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP.

Main Responsibilities:

  • Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
  • Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
  • Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
  • Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance's, SOPs etc.).

Additional specific roles/tasks

  • List individual specific activities (e.g.: as described in SOP QA Approval and Release responsibilities/authorities)
  • Receives incoming documents (e.g. executed batch records, vendor labels, etc.).
  • Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.
  • Scan, file and archive documents owned by QA. (e.g. Certificate of Compliance, Batch Record Review Checklists).

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor's or Master's degree in Science. Technicians with 5 years of experience also OK
  • Bachelor's with 3 years of experience
  • Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
  • Scientific, technical and regulatory knowledge in a specific area.
  • Basic knowledge of drug development.
  • Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines.
  • Good organizational skills
  • Fluency in English

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