Support Quality Systems processes related to Health Authority reporting, product complaint intake and assessment, adverse event management, and complaint sample coordination.
Leverage ability to support team members as they carry out manufacturing while upholding exceptional standards of safety, quality, and efficiency in accordance with documented procedures.
Compensation
Spectrum Plastics Group offers a competitive benefits package that prioritizes your mental and physical health, financial stability, family obligations, and professional growth.
Responsibilities
Adhere to and reinforce clean room safety and environmental standards
Understand production processes and regularly audit for compliance
Identify and communicate opportunities for continuous improvement
Build and maintain positive working relationships with employees, peers, and managers to ensure effective communication and professionalism
Provide clear directions to the team regarding daily, weekly, and monthly expectations
Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
Locations (3)
Ljubljana, Ljubljana, Slovenia
Madrid, Madrid, Spain
Barcelona, Catalonia, Spain
Compensation
Expected Annual Base Salary Range for role: Slovenia: EUR 46.900,00 - 87.100,00
Responsibilities
Support the strategic development of an effective global risk-based audit strategy and program
Plan, lead, conduct, document, and follow-up of GMP audit
Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing
Prepare audit reports according to NVS requirements and timelines
Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
Locations (3)
Ljubljana, Ljubljana, Slovenia
Madrid, Madrid, Spain
Barcelona, Catalonia, Spain
Compensation
Expected Annual Base Salary Range for role: Slovenia: EUR 46.900,00 - 87.100,00
Responsibilities
Support the strategic development of an effective global risk-based audit strategy and program
Plan, lead, conduct, document, and follow-up of GMP audit
Provide technical guidance, mentoring, and training on audit activities
Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing
Assure that Suppliers of Materials, Service Suppliers and Third Party Operations within the scope of QA&C meet applicable GSK and Regulatory requirements through remote document-based assessments and management of CAPA plans.
Responsibilities
Supplier assessment, approval & compliance
Performing Quality System assessments of assigned audits
Making a risk-based recommendation on the GxP approval status
Ensuring transparent, balanced, open communication with business stakeholders
Agreement of appropriate corrective and preventive action (CAPA) plans and follow-up
Requirements
Post Graduate/Graduate degree in relevant Science (Biology, Chemistry, Pharmacy) or Food / Chemical / Biotechnology or equivalent Engineering area of expertise
Responsible for performing admitting duties for all patients admitted for services at the hospital, including medical necessity checks, insurance processing, and customer service.
Compensation
This position pays between $20-25/hour based on experience
Responsible for performing admitting duties for all patients admitted for services at the hospital and ensuring compliance with regulatory requirements.
Compensation
This position pays between $17.00 - $18.15/hr based on experience
Responsibilities
Perform admitting duties for all patients admitted for services at the hospital
Assign accurate MRNs and complete medical necessity/compliance checks
Collect insurance information and process physician orders
Utilize overlay tool and provide excellent customer service
Operate telephone switchboard for incoming and outgoing calls
Quality Assurance SpecialistNewMerck · West Point, US