Senior QA Ops, Sterile Drug Product (Startup, 24/5)

Bristol-Myers Squibb Co; Cruiserath; In loco; EUR 70.000 - 100.000; Tempo pieno

Vantaggi offerti da questo lavoro

Annual bonus

Pension contribution

Family medical allowance

Life assurance

On-site gym

Descrizione del lavoro

Bristol Myers Squibb Cruisersath Biologics is seeking a Senior Specialist in QA Manufacturing Operations for Sterile Drug Product to support startup and commercial operations. You will oversee aseptic processes, collaborate with CQV/Automation teams, prepare critical documentation, and help drive operational readiness for a 24/5 shift during startup and ongoing production.

The role requires a BSc in science with 2–3+ years in QA Operations within Biologics or Pharmaceuticals, strong cGMP

Competenze

• BSc in Science or related discipline with a minimum of 2 - 3+ years’ QA Operations or related experience in a Biologics or Pharmaceutical environment.
• Detailed knowledge of cGMP requirements for manufacturing and/or systems and compliance.
• Must be able to work across a team matrix to meet accelerated timelines.
• Excellent communication and presentation skills are essential.
• Excellent time management and organizational skills along with a proven ability to multi-task.
• Employees are expected to display the BMS Biopharma Behaviors, which enable them to be successful and perform at their highest level.

Mansioni

• QA oversight for Aseptic Sterile Drug Product processes such as Formulation, Filling, Lyophilization, Capping, and AVI.
• Work with the project design, CQV, & the Automation/CSV teams to facilitate the implementation of the project design and validation of the project for Drug Product Operations.
• Prepare/Review/Approve documentation (SOPs, MBRs, Logbooks) required to enable manufacturing start-up and complete training on time.
• Support CQV / Tech Transfer / Operational Readiness activities including but not limited to: New Product Introduction SOP Development and Implementation Training Material development MES / MBR Design CQV support as required
• Develop and execute training programs in support of multiproduct manufacturing.
• Support establishment of Operational Excellence initiatives e.g., 5S / Std Work / LSW / Kaizen / Problem Solving etc.
• QA support of manufacturing operations (commercial operations and new product introductions).
• Batch record review and on-the-floor support of manufacturing activities.
• Provision of quality oversight for the inspection program.
• QA Operations review of events and investigations.
• Authoring, review, and approval of QA-related procedures.
• Review and approval of functional area documentation.
• Support the Disposition process for commercial and clinical drug product.
• Participation in GMP reviews for new facility construction and new equipment support systems.
• QA support for implementation of MES and development of batch records.
• Change control assessment and CAPA evaluation/CAPA close-out.
• Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
• Support external and internal audits.
• Drives and supports culture of continuous improvement initiatives and safe working practices.
• Designee for Manager, Sterile Drug Product, QA Manufacturing Operations, when required.

Conoscenze

QA Operations

Biologics

cGMP knowledge

Shift work

Team collaboration

Formazione

BSc in Science or related discipline

Descrizione del lavoro

Bristol Myers Squibb Cruisersath Biologics is seeking a Senior Specialist in QA Manufacturing Operations for Sterile Drug Product to support startup and commercial operations. You will oversee aseptic processes, collaborate with CQV/Automation teams, prepare critical documentation, and help drive operational readiness for a 24/5 shift during startup and ongoing production.

The role requires a BSc in science with 2–3+ years in QA Operations within Biologics or Pharmaceuticals, strong cGMP