Descrição da Função
Laboratórios BASI
– Industria Farmacêutica S.A. seeks to integrate a new employee into its
Quality Control team.
QC Planning and
Support – Technical Support
FUNCTION’S MISSION:
Ensuring the
compliance of CQ documentation, preparing and making available to analysts the
information they need to conduct the analyses and evaluate trend of results to
contribute to the improvement of the department.
RESPONSIBILITIES:
Collaborate in the
training and information of the collaborators in the QC, on suitable laboratory
methods, QC procedures and techniques.
Evaluate Change
Controls & CAPA with impact on QC (includes new products, new MPs, changes,
etc.), under occasional supervision.
Evaluate Authority
Requests within QC and plan and prepare timely response, under occasional
supervision.
Participate in the
implementation of improvement projects in quality control.
Analyze and track
OOS / OOT records, according to internal procedures.
Evaluate
specifications and methods in accordance with internal requirements.
Participate in the
preparation and review of the following QC documentation:
· Finished
product and raw material specifications in accordance with regulatory
information
· Technical
analysis instructions
· Analysis
order templates (finished product, stability, product in process, raw
materials, ...
· Stability
Reports (including stability trends)
· Analysis
reduction reports in QC
· IPCs
· Certificates
of analysis
Receive requests
for external services and participate in costing.
Perfil do Candidato
PROFILE:
Graduation or
Master Degree in an area relevant to the function.
Fluent English (spoken and
written)
Knowledge on chemistry,
classical chemical analytical techniques and analysis instrumental
Knowledge on Good
Manufacturing Practices
SEND
US YOUR CV TO: recrutamento@actradia.pt