Quality Assurance Officer (w/m) - Lisbon, Portugal
Chiltern source is currently looking for a Quality Assurance Officer to work for one of our client, a top leading pharmaceutical company based in Lisbon. Available in October 2016, candidates will be employed through Chiltern to provide their services to a global pharma company. This position is part time (open to freelancers), but a full time permanent contract can be considered, to be office based at Chiltern's office and dedicated to the client.
Job primary functions:
- The Primary QA contact for the Affiliate. The goal of this function is to ensure global quality practices are integrated in the affiliate to ensure compliance and secure compliance with safety obligations within the company and local regulations.
- Create and implement the Quality Manual, following the sponsor's procedures and SOPs, define appropriate Key Quality Indicators, and Quality Risk Management Assessments.
- Inspection and approval of each batch to be released to the Portuguese Market according to the requirements as defined by sponsor and local requirements including final evaluation of deviations with regard to their impact on the quality of drugs.
- Ensure Affiliate readiness for all regulatory inspections and management of those inspections.
- Ensuring that any deficiencies, observations identified through audits or other means are addressed through the timely implementation of effective appropriate corrective and preventive actions.
- Ensure the appropriate management of Project Leads based on quality agreement in place as well as the compliance with cGDPs: returns, destructions, deviations, complaints, shipping conditions, etc ensuring that GDP requirements are followed and drive a QP decision.
- Ensure all Quality deliverables are completed in a timely manner in accordance with Global SOPs (e.g. follow up and closure on all relevant complaints, deviations, CAPAs and change controls). Tracking and archiving according appropriate Sponsor's tools.
- Lead if necessary local recalls.
- SOPs: Support in the creation/review according national legislation and Sponsor Quality requests, and the relevant translation into Portuguese language, when necessary;
- Retention and archiving all Quality related documentation
- Manage Products' recall, following the directions issued by Sponsor and meet the local requirements, including reconciliation in coordination with local PLO and local QP
- 2 years minimum experience in Quality Assurance
- Candidates must have experience in pharmaceutical Quality Assurance
- Experience in regulatory affairs and pharmacovigilance would be appreciated but isn't mandatory
- Good level of English mandatory
If you are interested, please send your current please send your application to and refer to the following job reference: QAO