3 days ago

QA Specialist

Stamford Consultants AG

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 " Specialized Talent Building is in our DNA"


 


By igniting the human potential within organizations, we serve as a catalyst for growth, transformation, and high performance. The Stamford Group consists of two companies: Stamford Consultants and Talentis Solutions, providing bespoke sourcing solutions since more than 15 years. Headquartered in Basel with regional offices in Zurich and Geneva area,  we specialize within the Life Sciences and Information Technology sectors. Our international team, from more than 10 nations, supports customers to build internal high performance teams, whether this requires a full project team, on-site contractors, permanent hires or executive search.


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                                                                                                   Find out more about our current needs

QA Specialist

" Specialized Talent Building is in our DNA"

By igniting the human potential within organizations we serve as a catalyst for growth transformation and high performance. The Stamford Group consists of two companies Stamford Consultants and Talentis Solutions providing bespoke sourcing solutions since more than 15 years. Headquartered in Basel with regional offices in Zurich and Geneva area we specialize within the Life Sciences and Information Technology sectors. Our international team from more than 10 nations supports customers to build internal high performance teams whether this requires a full project team on-site contractors permanent hires or executive search.
Join our talent community here
Find out more about our current needs QA Specialist Our Client is an international biophamarceutical company. to support their activity they are looking for
QA Specialist 1 year

RESPONSABILITIES

Follows all applicable SOP's and enforces them. Ensures compliance with the relevant internal and regulatory requirements.
Supports the release/disposition of specified intermediates manufactured
Reviews manufacturing procedures analytical procedures specifications and changes thereof on site. Supports implementation
Reviews batch records and/or reviews and coordinates reports of the Batch Record Review Team lists of observations .
Initiates revises and evaluates local Change Requests. Supports implementation of Change Requests.
Supports issuance of Batch Summary Reports and the release process for final API batches
Supports the compilation of the Product Quality Reviews
Ensures compliance of labels
Supports the response to quality-related internal customer requests in a timely and correct manner
Supports the Associate Director QA Operations and the Director QA Operations in quality related aspects e.g. preparation of authorities' inspections and internal audits
Participates in self-inspections and external audits
Supports the monthly trending of selected KPIs monitoring
Supports the training of the chemical operators on GMP topics on a yearly basis.
Supports an electronic archive of all locally relevant GMP documents and manages respective electronic systems.


PROFILE

between 1 and 3 years of experience in Quality Control Quality Assurance and/or Manufacturing in a pharmaceutical company or other related industry
Education in Life Science
Good understanding of cGMPs and EU and FDA regulatory requirements
Good understanding of API manufacturing processes and QC testing
Ability to focus attention to details
German B2 ideally

Rue Neuve 4 1260 Nyon