Sr Specialist QA Operation (Fixed term Contract - 18 months)
Location: Boudry Neuchâtel NE
Category: Quality Assurance / Quality Control
Industry: Pharmaceutical Manufacturing
Position: Entry level
Job type: Full-time
Job contentAt Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.CompetencesQA Operations team is committed to actively supporting Celgene/BMS Boudry Manufacturing site and other departments to ensure cGMP compliant production, testing and release of products on the Boudry manufacturing site. This position is responsible for quality assurance (QA) involved primarily with the support of the different quality system tools in place to ensure cGMP compliance throughout the Boudry manufacturing site.You will be responsible for the assigned processes and activities within QA Operations and will act as a member of the team supporting site operations. The Scope included within this position is wide and includes bulk manufacturing, semi-finished and finished goods production, warehousing, and support functions such as metrology, maintenance, and projects.The activities include responsibility for execution of the main following processes: deviation and CAPA, change control handling, QA oversight of validation and qualification activities and support for new product/equipment introduction. Additional tasks are batch record review, risk assessments, as well as the support of health authorities’ inspections and corporate audits.The Senior Specialist, QA Operations can be assigned special tasks in cross-functional projects to support Boudry manufacturing site activities like new product introduction and launches.This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance-related issues, ensure lean release of batches, raw materials for production, as well as to contribute to process improvement in his/her scope of activity.This position will also support quality on the floor for manufacturing, packaging, and warehousing activities in collaboration with the other members of the team of quality operation. The team works closely with the QA operation release team to achieve the site objective and release the products on time. As part of the quality on-the-floor organization, a capability to solve issues on call is required.The Senior Specialist QA is also a key member of the site governance through the tier meetings processes. You will be responsible to address the quality topics, take appropriate decisions at the right level, and bringing any escalation to management if necessary, in a clear and factual manner. This position is key to facilitating problem resolution at the right level.The Senior Specialist, QA Operation is capable of working autonomously, carrying escalation and following all the topics from start to end in a proactive manner and behavior.Skills/Knowledge Required
- At least 5 years of experience in a pharmaceutical company or other related industry.
- BS or MSc in Science or related field.
- Good understanding of cGMPs and FDA regulatory requirements.
- Good understanding of solid oral dosage form manufacturing processes is preferred.
- Proven interpersonal, collaborative and organizational skills. Ability to handle several tasks simultaneously.
- Thorough understanding of cGMP requirements
- Works independently on routine tasks, makes proposals and facilitate decision when escalation is needed.
- Ability to focus attention to details and analytical thinking
- Good written & oral communication skills.
- Excellent Investigational and problem-solving skills.
- Good Knowledge of most common office software (Microsoft Office).
- Supports the deviation process. Ensure (and lead if necessary) that the initial quality assessment is completed in a timely manner according to requirements, support investigators and assess the criticality, review and approve the deviations and related CAPA.
- Support the CAPA process by approving all the CAPA plan, and the completed action. Ensure review and approval of effectiveness check.
- 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 in support of the Quality release team.
- Contributes to risk assessments, e.g. related to quality issues or projects like new product introduction.
- Represents QA within department and cross-functional project teams according to assignments.
- Acts as backup for colleagues within QA Operations team.
- Contributes to SOP/WP revision. Can take ownership of processes and document revision
- Supports health authorities and internal inspections in different roles (SME, coordinator, etc…)
- Participate to Quality KPI establishment and monitoring
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