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Quality Specialist
Pharmaceutical Product Development (PPD)
Vilnius, Lithuania
Job Description
KEY Responsibilities:
- Work as part of Vilnius site Quality team to support the function including auditing of internal supplier performance and systems & processes.
- Maintain internal supplier approval status through review and approval of new requests and change requests as per applicable standard or requirements.
- Lead and own the execution of objectives for the control of internal suppliers, in alignment with goals of the company and objectives.
- Ensure alignment between internal suppliers and related quality requirements and specifications.
- Develop, implement, and maintain appropriate metrics to assess internal supplier performance. Provide timely and accurate communication to team on internal supplier performance metrics.
- Lead meetings related to internal supplier performance monitoring, issue resolution, strategy definition for specific suppliers.
- Support processes for new material qualification, end of life materials/components, product development, internal supplier requests for material changes and sustaining engineering.
- Drive problem solving and root cause analysis activities with internal suppliers to eliminate recurrence of non‐conformances.
- Collaborate with other departments effectively to define actions and priorities for internal supplier related quality issues.
- Support the Material Review Board meetings and other critical decision-making meetings as required to define internal suppliers' responsibilities and effectiveness.
- Align with Purchasing to report internal supplier performance while monitoring ratings and uncooperative internal suppliers.
- Develop relationships with critical internal suppliers to support the business.
- Work with relevant business Unit leaders to facilitate integration of new internal suppliers.
- Review and assess internal supplier notification of change and communicate accordingly.
- Ensure issues such as delays in audits, delays in raw material non-conformity investigation etc. are prioritized appropriately and resolved effectively.
Requirements for qualification / Education / Experience:
Minimum Requirements/Qualifications:
- Bachelor’s degree (or higher) in engineering, science or operations.
- Strong English language communication skills both written and verbal.
- Project planning and working knowledge of Excel, Word, Access, and quality management software.
- High ethical standards to support a professional business code of conduct.
Other Qualifications:
- Quality auditing certification (ISO9001, ISO13485) preferred.
- Demonstrated experience on requirements of Quality Management System (ISO9001, ISO13485, CFR Part 820) and Good Manufacturing Practice (GMP).
- Knowledge of Quality Systems (ISO9001, ISO13485, CFR Part 820), IVD/medical device/Pharma manufacturing and regulatory requirements over a number of years.
- Well-versed in the development and execution of quality management systems.
- Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
- Leadership skills: Proven ability to influence others, lead significant change and negotiate for win/win outcomes.
- Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgment, decision making and ambition.
The annual minimum and maximum salary range is €21,800.00 to €32,675.00, respectively.
This translates to a monthly salary range of approximately €1,816.67 to €2,722.92 before taxes.
Compensation and Benefits
The salary range estimated for this position based in Lithuania is €23,800.00–€35,650.00.Job posted: 2024-03-14