Reporting to the Director of Quality, the responsibilities of this position include butare not limited to the following:
Ensuring that duties carried out in accordance with Article 22 of Directive 75/319/EEC and Annex 16 of Volume 4 of the Eudralex.
Release of each batch of product in accordance with SOP, ensuring that the requirements of cGMP, the Manufacturing Authorisation & the Manufacturing Licence are met.
Ensuring that all manufacturing checks and tests have been performed in accordance with the approved procedures and account taken of production conditions and manufacturing records and that all production and QC documentation has been completed and endorsed by appropriate qualified personnel.
Ensuring that any additional sampling, inspection or analysis have been carried out or initiated as appropriate to cover planned changes or deviations.
Assignment of batch disposition and allocation of batches for dispatch.
Liaison with contract manufacturers in relation to Quality Agreements and requirements for QP Batch Release.
Assessment of Deviations, Quality Alerts and Out of Specification investigations.
CAPA assessment and review.
Periodic Quality Review compilation & approval.
Assessment & disposition of returned goods.
Requirements:
Candidates must possess a relevant third level Scientific Degree.
Eligibility to be nominated as a Qualified Person on the Manufacturing Licence is mandatory.
This role will require excellent communication skills, strong organisational abilities and effective leadership skills. Ability to interpret data and attention to detail as well as proven initiative are pre-requisites
Due to the short-term nature of this contract it is essential that all applicants have the relevant knowledge and experience to perform the key responsibilities of the position, as well as having the required qualifications.
Package:
Contract rate - Negotiable based on experience
Minimum Contract duration: 12 months
Job Description
Reporting to the Director of Quality, the responsibilities of this position include butare not limited to the following:
Ensuring that duties carried out in accordance with Article 22 of Directive 75/319/EEC and Annex 16 of Volume 4 of the Eudralex.
Release of each batch of product in accordance with SOP, ensuring that the requirements of cGMP, the Manufacturing Authorisation & the Manufacturing Licence are met.
Ensuring that all manufacturing checks and tests have been performed in accordance with the approved procedures and account taken of production conditions and manufacturing records and that all production and QC documentation has been completed and endorsed by appropriate qualified personnel.
Ensuring that any additional sampling, inspection or analysis have been carried out or initiated as appropriate to cover planned changes or deviations.
Assignment of batch disposition and allocation of batches for dispatch.
Liaison with contract manufacturers in relation to Quality Agreements and requirements for QP Batch Release.
Assessment of Deviations, Quality Alerts and Out of Specification investigations.
CAPA assessment and review.
Periodic Quality Review compilation & approval.
Assessment & disposition of returned goods.
Requirements:
Candidates must possess a relevant third level Scientific Degree.
Eligibility to be nominated as a Qualified Person on the Manufacturing Licence is mandatory.
This role will require excellent communication skills, strong organisational abilities and effective leadership skills. Ability to interpret data and attention to detail as well as proven initiative are pre-requisites
Due to the short-term nature of this contract it is essential that all applicants have the relevant knowledge and experience to perform the key responsibilities of the position, as well as having the required qualifications.
Package:
Contract rate - Negotiable based on experience
Minimum Contract duration: 12 months
We need : English (Good)
Type: Permanent
Payment: package
Category: Pharmaceutical
