Concordia International looking for Assistant Manager - Batch Compliance
Concordia International is the result of the acquisition by Concordia Healthcare Corp (now Concordia International Corp) of the AMCo group on 21 October 2015.The combined businesses are highly complementary to each other, with well established product portfolios, and provide a strong platform for future growth through acquisitions in line with its strategy to build a truly global pharmaceutical company.
Post : Assistant Manager - Batch Compliance
MAIN PURPOSE OF ROLE:
The main responsibility of this job is to ascertain every batch of products manufactured for US market is released ONLY if it meets the requirements of relevant procedures at Concordia by:
Assessing the batch documents received from Contact manufacturers Documenting detailed Risk Assessments for every batch in support of the release/ reject decision.
It is also expected that the candidate will provideguidance on US regulations and support other functions of Quality department in resolving critical quality incidents.
•To establish suitable procedures in support of batch release where applicable and ensure that they are thoroughly followed , constantly reviewed and updated to meet the regulatory requirements.
•To perform an accurate and timely review of batch documents along with shipment conditions and confirm that the batch meets the relevant standards before being placed on the US market.
•To prepare a risk assessment report in support of the batch release decision according to internal procedures.
•To ensure that the relevant checklists and forms are filled and a database is maintained for every batch released to the US market.
•To liaise with Supply Chain Management team on product deliveries and plan quality actions according toalign business priorities.
•To coordinate actions related to release of a batch with Manufacturers and relevant groups within Concordia
•To log and support investigation of relevant deviations following the review of documents related to batch release.
•Provide guidance on US regulations and support other functions of Quality in resolving critical quality incidents.
•Prepare and present monthly reports during the Quality Management Review meetings.
•Providing accurate information to the business on product availability.
•To participate in Self inspections and other projects relating to improvements in Concordia Quality Systems.
Degree in Pharmacy, Chemistry or Microbiology
Masters Degree in Chemistry, Pharmacy or Microbiology
Sound working knowledge of Microsoft Office applications
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