Senior Specialist, QA Operations

Req #: 1803532
Location:Boudry, NeuchatelCH
Job Category:Quality
Work Location: Route de Perreux 1 BOUDRY 2017
Organization: Celgene International SaRL
Schedule:40
Shift:
Employee Status: Full time
Job Type: Regular
Job Level:
Travel:
Other Locations:Switzerland- Boudry

Description

Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health.  We value our passion for patients, ​quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.

Skills/Knowledge Required

• At least 5 years of experience in a pharmaceutical company or other related industry, ideally in Quality Assurance.


• BS or MSc in Science or related field.


• Thorough understanding of cGMPs and FDA regulatory requirements.


• Very 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 including complex cases, 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).

Duties and Responsibilities

• As per defined assignment, ownership of one or several local processes (deviations and CAPA, change controls). Responsibility includes coordination of day to day activity, maintenance of associated documentation, participation of process enhancement and training of new users.


• Supports the deviations and CAPA process by handling deviations and CAPA and executing investigations within assigned areas of responsibility.


• Supports the change control process. Performs action plan evaluation and coordinates change control progress within assigned areas of responsibility.


• Reviews and approves as QA representative qualification and validation activities documents (protocols, reports,…).


• Perform batch record review and prepare batch release documentation.


• Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.


• Supports health authority inspections and corporate audits as SME and case by case, participate to internal audits.


• Represents QA within department and cross-functional project teams according to assignments.


• Manages complex tasks, involvement in cross-functional topics including other Celgene entities and Corporate.


• Assists with writing SOPs and makes recommendations for SOP revisions for the Quality Operations and supported departments of Boudry manufacturing site, as well as at a global level as local process owner.


• Acts as backup for colleagues within QA Operations team.


• Acts as deputy for Manager QA Operations for operational activities.


• Provides coaching and guidance to less senior personnel in QA Operations team.

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