QA/QP

We are searching for a QA/QP for 6 months consultant assignment at multinational gas company in Enköping.

Do you like working with quality? Do you want to ensure patient safety every day?
This is the job for you!

We are now searching for a QA/QP for a 6 months consultant assignment, with good possibilities to a permanent employment, at a multinational gas company in Enköping.

Principal responsibilities as Qualified Person (QP) for Manufacturing:


* Responsible for release of raw materials, intermediates and finished medical gases and special medical gases according to specifications, GMP and Marketing authorization (MA)
* Ensure Quality System is implemented and maintained
* Relevant personnel are trained
* Accountable for decision for recall in corporate with QAM and with MPA
* Ensuring customer complaints are dealt with effectively
* Deviation handling system is in place, supporting deviation investigations and approval of major deviations
* Ensuring suppliers and customers are approved
* Approving any subcontracted activities which may impact on GMP
* Ensuring internal audit program in place and be part of audit team.
* Deciding on the final disposition of returned, rejected, recalled or falsified products
* Accountable for the batch documentation
* Responsible for visiting medical Air Separate Units (ASU) and medical filling sites at least twice/year
* Approve validation and qualifications


Principal responsibilities as Quality Assurance (QA):

Establishing and ensuring QMS i.e prepare implementation and monitor standards and processes, within the Quality Assurance area:

* Traceability
* Deviations and complaints
* Change Control
* Corrective Actions and Preventive Actions
* Nonconformance
* Audits (internal and external)
* Support validated manufacturing processes and systems.
* Execute training, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmacovigilance in local country
* Maintain and update training material
* Execute training of new QA employees
* Local adaptation of Module 3 (manufacturing and analytical part in regulatory dossier)
* Establish and continuously improve the Quality Management System
* Participate in projects
* Archiving (batch records, training records etc.)
* Preparation and pre approval of relevant batch documentation according to tasks above
* Receiving control of medicinal gases filled at other sites


Establishing and ensuring QMS i.e prepare implementation and monitor standards and processes, within the Quality Assurance area:

* Traceability
* Deviations and complaints
* Change Control
* Corrective Actions and Preventive Actions
* Nonconformance
* Audits (internal and external)
* Support validated manufacturing processes and systems.
* Execute training, Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and pharmacovigilance in local country
* Maintain and update training material
* Execute training of new QA employees
* Local adaptation of Module 3 (manufacturing and analytical part in regulatory dossier)
* Establish and continuously improve the Quality Management System
* Participate in projects
* Archiving (batch records, training records etc.)
* Preparation and pre approval of relevant batch documentation according to tasks above
* Receiving control of medicinal gases filled at other sites


Other accountabilities(QA/QP):

* Contribute to further upgrading to a Pharmaceutical Gas Company cross-functional co-operation and standardisation within REN
* Within given frames help people develop the idea of quality as a tool for patient safety and best practise way of working
* Relevant standards and documents in Linde Healthcare Quality Management System as i.e LiMSS and Documentum

Authorities

* Stop production due to problems that might influence on product quality
* Quality approval of process description, SOP´s, specifications and forms in Linde Healthcare

Required qualifications/experience:

* Experience from GMP, GDP, ISO, Medical Device Directive
* Experience from GDP and/or GMP for minimum of 2 years
* Fulfill qualification for Qualified Person acc. to LVFS 2004:7
* University degree in Pharmacy, Chemistry or similar
* Language skills: English and Swedish


Desirable qualifications/experience:

* Good knowledge in Quality Management
* Good knowledge in EU pharmaceutical legislation,GMP, GDP and Medical Device Directive
* Good collaboration and co-operation skills
* Decision making and execution
* Negotiation & Conflict Resolution

Get in contact
If you want to apply for this role, please push the Apply button and attach your CV, if you have further questions please don´t hesitate to contact me at ida.holmberg@hays.com.