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Operations Manager

2 mesi fa

Montà, Italia Novartis A tempo pieno

About the Role

Responsible for developing, implementing, and managing site performance qualifications and requalification of existing equipment and cycles as well as any new equipment. This includes developing, implementing, and managing site process validation, primary packaging validation, process performance qualification, cleaning validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget.

Main Accountabilities:

  • Support Product Steward in maintaining the process control strategy.
  • Provide technical expertise and facilitate establishment of Quality Risk Assessment (as needed).
  • Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product-specific data trending.
  • Participate in transfers and launches by aligning on the product validation approach.
  • Ensure equipment is in a qualified state and qualified ranges are aligned to meet process parameters.
  • Assess impact of technical changes, assess their technical feasibility, and determine scope/design of technical batches, challenge technical risk, and business benefit of technical changes proposed.
  • Contribute to registration strategy and support registration activities providing experimental data obtained during the validation activities, which will be used to prepare related registration documentation.

Responsibilities:

  • Establish a qualification and requalification program (PQ) for the site and execute activities according to plan and defend to authorities.
  • Perform equipment periodic reviews according to internal procedures.
  • Define and implement validation strategy (process, cleaning, ongoing verification) and defend to authorities.
  • Overall responsibility for establishment, prioritization, execution, and tracking of Validation Master Plan for process, cleaning, packaging validation, and ongoing process verification (OPV).
  • Maintain all validation activities in an inspection-ready status.
  • Author validation protocols and reports.
  • Establish local procedures & templates for respective validation documentation.
  • Ensure that all Site validation activities are performed and are in line with the current AAA (or applicable) Novartis requirements and cGMP, handling any deviations associated with these activities including oversight of pre-validation and validation resulting from technical changes.

Benefits and Rewards:

We offer a competitive salary range between €70,000 - €100,000 per year, depending on experience. The exact salary will be discussed during the interview process. Additionally, we provide excellent benefits and rewards package, including health insurance, retirement plan, and paid time off.

About Us:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. We help people achieve their ambitions by delivering high-quality medicines, innovative medical technologies, and professional services through our three divisions: Innovative Medicines, Sandoz, and Alcon.

Location:

The role will be based in Saluggia, Italy, and will require occasional travel to other sites within the region.

Job Type:

This is a full-time position with a regular employment contract.