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QA Compliance Specialist - Switzerland  

Celgene (company)


Posted on : 21 March 2017

Project Description

Req #: 17000476 Location: COUVET, NE CH Job Category: Manufacturing/Technical Operations Work Location: Couvet, Switzerland Route des Nasieux 18 Couvet 2108 Organization: Celgene International SaRL Schedule: Full-time Shift: Day Job Employee Status: Regular Job Type: Standard Job Level: Individual Contributor Travel: No DescriptionQA Compliance is committed to actively support Celgene International manufacturing site and otherdepartments to ensure cGMP compliant processes on the Boudry manufacturing site.This position is responsible for quality assurance (QA) involved primarily with the support of the differentquality system tools in place to ensure cGMP compliance throughout the Boudry manufacturing site.The position holder will be responsible for the assigned processes and activities within QA Complianceand will act as member of the Quality Surveillance team.The activities include responsibility for execution of the main following processes: internal audits, annualproduct review reporting and suppliers qualification.Additional tasks are the support of health authorities inspections and corporate audits, monitoring ofregulatory changes, response to regulatory authorities requests, QA oversight on contract manufacturing/ testing partners, deployment and execution of annual GMP training and reporting of quality processesmetrics..The QA Compliance Specialist can be assigned special tasks in cross-functional projects to supportBoudry manufacturing site activities like introduction of new product on the manufacturing site.As a member of the Quality Operations department, this position will be working closely with the QACompliance management to identify and handle process quality and cGMP compliance related issues.a. Supports internal audits plan by executing self inspections and following-up on action plans.b. Supports the supplier qualification process by assisting in material supplier and vendor   evaluation and approval. The position holder may participate in external audits as Celgene   audit team member, QA liaison or subject matter expert (SME). Provides support for vendor   and supplier contract setup and modification, as needed. Is responsible to handle deviations,   CAPA and change controls related to suppliers.c. Generates annual product reports for products made on Boudry manufacturing site.d. Supports preparation and execution of authorities inspections and corporate audits in different   roles (i.e. back office, subject matter expert, note taker or runner).e. Performs QA oversight of assigned contract manufacturing / testing partners as assigned.f. Informs on regulatory changes and coordinate assessment and action plans with SMEs.g. Provides response related to regulatory authorities requests, e.g. in the scope of submission or   periodic GMP review.h. Supports the deployment and execution of GMP training intended for all Boudry manufacturing   site departments involving GMP activities.i. Contributes of regular reporting of quality processes metrics for different review meetings.j. Ensures the representation of QA within department and cross-functional project teams   according to assignments.k. Assists with writing SOPs and makes recommendations for SOP revisions for the Quality   Operations and supported departments of Boudry manufacturing site.l. Acts as deputy for colleagues within QA Compliance team.m. Can be assigned ownership  of QA Compliance processes, including coordination of day to   day activity, maintenance of associated documentation, participation of process enhancement   and training of new users.*Li-Ex*MONEUQualifications- At least 3 years of experience in a pharmaceutical company or other related industry, ideally in  Quality Assurance.- BS in Science or related field.- Very good understanding of cGMPs and regulatory requirements.- Good understanding of solid oral dosage form manufacturing processes and QC testing  methods are preferred.- Excellent interpersonal, collaborative and organizational skills.- Works independently on routine tasks, makes decisions for minor issues.- Ability to focus attention to details.- Very good written & oral communication skills.- Very good investigational and QA problem solving skills.- Knowledge of most common office software (Microsoft Office).

Locations

COUVET NE CH

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