Celgene Associate Specialiste Quality Assurance in BOUDRY, NebraskaSwitzerland
This position is involved primarily with quality assurance (QA) review of bulk and commercial drug products.
The position holder will maintain working relationships between QA department and the other departments, suppliers. The position will support QA activities on the manufacturing site of Boudry and third party manufactures and is expected to be a reliable source of information and interpretation of quality and cGMP compliance requirements.
Duties and Responsibilities
The position holder is responsible and accountable for the tasks given below. The list of tasks is non exhaustive, according to business needs other tasks might be assigned to the position holder.
Responsible for the review of master and executed batch records, bill of materials, packaging masters.
He/she ensures that all changes to the process are captured through proper change control practices.
Responsible for the review of master and executed batch records of drug product validation as appropriate. He/she ensures that all changes are captured through proper change control practices.
Assists with the review and archiving of the stability and release raw data, analytical documentation and reports for compliance to GMP, as appropriate (mainly refers to stability testing performed by Celgene International).
Assists with the review and archiving of the method development and validation raw data, analytical documentation and reports for compliance to GMP as appropriate.
Supports in managing the change control for equipment, methods, launches and
specifications, as assigned.
Writes new and/or revises Standard Operating Procedures and quality documents.
Circulation (to supervisor) of approval, or rejection of, any necessary or related OOS and deviation reports.
Ensures recording ExBRs and documents into the shared drive, folders and data base.
Ensures the follow up of the dossiers in the archive room as assigned.
Supports the requests either from the stakeholders (internally/externally) or the CSPs as appropriate.
Assists in the qualification of suppliers and CSP as assigned, and according to the procedure.
Ensures preparation for the approbation of artworks. Approves good to print and updates the R.M.F as appropriate. Gives support for the launches of new products within assigned areas of responsibility.
Reviews, approves and executes the status changes of raw material, bollini in the electronic systems, as appropriate.
Supports International Quality Operations during audits by participating, when requested as a subject matter expert for International Quality Operations.
Ensures the follow up of the retention samples according to Batch Release Office procedure as assigned.
Acts as deputy for colleagues within the Batch Release Office team.
Supports QA activities including participation in various project Tech ops, CSP and Quality operations as advised.
Participates to recommendations for continuous improvements in Quality systems as required.
Responsible for training other BRO team members and instilling the awareness of quality aspects.
BS/BA/degree or equivalent in Life Science or relevant discipline.
At least 3 years experience in Quality Assurance and/or Quality Control position in a
Good working knowledge of the cGMP and their practical application in a pharmaceutical
Solid understanding of manufacturing process and test method development requirements,
both scientific and regulatory.
Strong written and verbal communication skills, organizational and computer skills.
Ability to work independently, yet effectively in a team oriented environment.
Excellent investigational skills and QA problem solving skills, has a keen eye to identify quality.
Capability to pay attention to detail.
Sense of responsibility and reliability.
Ability to handle multiple tasks while working against pressures of deadlines.
Sense of team spirit, initiative and service.
Associate Specialiste Quality Assurance
Location: BOUDRY, NE, CH
Job ID: 17001156