Quality Assurance Lead- Sweden Biologics
AstraZeneca Södertälje / Chefsjobb / Södertälje
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hela Sverige At AstraZeneca every one of our employees makes a difference to patient lives everyday.
We have an exciting opportunity for you to join our new Biologics Protein Therapeutics Filling and Packaging facility based at the AZ Gartuna Site in Sodertalje, Sweden.
As Quality Assurance Lead you are responsible for the leadership and management of the Quality Assurance Department including managing all Quality Assurance and Compliance activities at the Sweden Biologics facility specifically Quality Operations/Projects and Quality Systems
As the European Qualified Person (QP), you are the primary contact for the Swedish authorities.
As part of the collaboration with Site Leadership Team., you will play a key contributing role in defining and implementing the values, cultures, goals and strategies of the site.
Main Duties and Responsibilities
Ensure that roles, responsibilities and reporting lines are clearly defined throughout the organisation, to assure a functionally independent quality unit.
Ensure sufficiently trained resources with adequate product and process knowledge for execution of GMP/GDP obligations and on-going professional development to maintain proficiency.
Ensure development of and continuing suitability and effectiveness of the quality management system.
Ensure product quality and GMP/GDP compliance through leading quality management review. Accountable for initiation, development, implementation and maintenance of Compliance improvement plans and accountable for the timely deliverables of Quality project outputs. Issues and risks are timely flagged and escalated
Ensures that the organisation complies with the relevant cGMPs (e.g. EU, FDA, Japan), health and safety, timekeeping, budgeting, regulatory legislative requirements and in accordance with the rules and requirements of the GMP Compliance Rule book, the Code of Conduct, quality manual and any other company policies and standards concerning the manufacturing and control of the drug product and participates fully in the audit program, performed by the Regulatory Products and ensures that corrective action plans are agreed, implemented, monitored and completed in order to maintain compliance.
Responsible for the quality oversight program which includes real time overview of manufacturing activities inside and outside of aseptic areas, QC and project related activities. The program must result in full adherence to procedures.
The role will be accountable for assuring that the quality of commercial finished products and Investigational Medicinal Products manufactured at the Sweden Manufacturing Facility are manufactured, tested, labelled and packed in compliance with marketing licenses and compliant to cGMP and Corporate guidelines prior to the release for further manufacturing or final release and distribution to the market
Essential Requirements
You have been certified as a Qualified Person by the local government and acts according QP duties as laid down in EU GMP, volume 4, annex 16. Review and approve Product Market Corrections and Recalls (within the EU)
Master degree in Pharmacy, Biochemistry or Chemistry
Language level: Very good skills in both Swedish and English.
For full job description and to apply, please visit
www.astrazeneca.seVaraktighet, arbetstid
Tillsvidare
Heltid
Publiceringsdatum2016-10-18ErsättningFast månads- vecko- eller timlön
Så ansöker duSista dag att ansöka är 2016-11-13
Ange följande referens när du ansöker: R-000453
FöretagAstraZeneca Södertälje
AdressAstraZeneca Södertälje
Karlebyhus, Astraallén
15185 Södertälje
KontorsadressGärtuna
Södertälje
Övriga kontaktuppgifterTelefonnummer: 08-553 260 00
Jobbnummer 3112721
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