Associate QA

Locatie: Breda, Noord-Brabant, Nederland
Salaris: competitive
Sectoren: Quality Assurance
Soort functie: Freelance
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Currently, I am looking for an Associate QA for a pharmaceutical company in Breda.

Incoming Quality Asssurance

Expectations/scope/complexity
Knowledge
Knowledge of basic principles, methods and practices of scientific/technical field
Typically obtained through formal study
General knowledge of procedures and activities within own work area
Ability to relate day-to-day work to business priorities
General understanding of industry practice and standards

Problem Solving
Applies broad-based research, information gathering and analytical skills to factual information
Selects appropriate alternatives from defined options
Collects required documentation/raw data; verifies conformance of documents
Assesses accuracy of detailed information
Tracks, maintains and produces regular work products
Ability to identify roadblocks to task completion and effectively brings them to line managers for resolution

Autonomy
Works under general direction, seeks assistance as needed
Completes work in accordance with established procedures and practices within field of scientific/technical knowledge
Establishes approaches for completing assignments
Work requires consistent exercise of discretion and independent judgment
Works with team to support achievement of project milestones

Contribution
Contributes to own work group/team through quality and accuracy of own output
Builds productive internal/external relationships

Objectives
Ensure IDP/ FDP batches are ready for release by the QP and all procedural requirements for release have been met.
Execute sampling, inspection, review and release of incoming materials.
Execute sampling and/or inspection of IDP / FDP / NAMP.
Initiate and own class 1 deviations related to IQA and WH activities.
Establish effective working relationships with WH, QA management and the QP.
Perform complaint return and reserve sample inspection

Position Specific Tasks
Sampling and Inspection of IDP and review completed IDP batch records ensuring all procedural requirements are met
Sampling and Inspection of FDP and review completed FDP batch records ensuring all procedural requirements are met
Sampling, inspection, review and release of printed and non-printed packaging components
Sampling and inspection of "Non Amgen Medicinal Products"
Review temperature data of shipments received at ABR
(Additional) Sampling and Inspection of drug products as needed
Preparing samples for shipment to contract laboratories
Provide QA oversight for:
Regulatory labeling in the WH
Issues upon receipt of components / IDP / FDP / NAMP
Destruction Authorizations
Cancelled Ship Confirmed Orders
Support the complaints lab
Perform receipt of reserve samples
Perform complaint return and reserve sample inspection
Prepare shipments of return samples
Initiate and own class 1 deviations related to IQA and WH activities
Own training material related to own processes.
Trainer for IQA related processes.

Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge or the equivalent.

Minimum Requirements
High school diploma, associate's degree, bachelor's degree, professional secretarial education or equivalent
Pharmaceutisch vakman certificate
Pass Amgen's test for colorblindness
Accurate mindset

Preferred Requirements
Pharmaceutisch Technicus certificate
Typically 3 or more years related professional experience, preferably in the pharmaceutical industry

Are you the new Associate QA or do you know someone who would be perfect for the job? Apply online or to speak to a consultant about this project, contact Lauren Dikmans via +31 (0)20 522 1588 or l.dikmans[at]realstaffing.com

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