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Concordia International looking for Assistant Manager - Batch Compliance

 

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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.

 

KEY RESPONSIBILITIES:
•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.

Qualifications
Degree in Pharmacy,  Chemistry or Microbiology
Masters Degree in  Chemistry, Pharmacy or Microbiology
Sound working knowledge of Microsoft Office applications

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Experience & Competences
Minimum 5 years’ experience of working in a cGMP Quality Systems within a reputed pharmaceutical company approved by USFDA.
7 years Experience working in a virtual company environment
Experience working in MHRA / USFDA approved company
Capable of working to deadlines & remain calm under pressure
Proven ability to organize and prioritize tasks
Ability to work on own initiative
Ability to work effectively as part of a team

Knowledge & Skills
Thorough knowledge of cGMP, GDP, Eudralex and 21 CFR
Excellent communication skills, both oral and written, to include senior management in third party suppliers
Well organised with logical & methodical approach to work
Investigation skills
Sound decision making and problem solving skills    
Good organisation & time management skills

Personal Qualities
Methodical, hardworking individual who can work on their own initiative
Ability to adapt to change
Even tempered, positive personal, open and approachable
Helpful & flexible with strong team spirit

Additional Information:
Experience : 5-7 years
Qualification : B.Sc, B.Pharm, M.Pharm, M.Sc
Location : Mumbai
Industry Type :  Pharma
Functional Area : Quality Control and Release
Last date : 30th January, 2017

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