Sr. QA Specialist
2 weeks ago
Requisition ID 499890 - Posted 07/06/2023 - Region (1) - Country (1) - Location (1) - Regular Full-Time - Quality
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Job Title: Senior Quality Assurance Specialist
Reports: Manager, Quality Assurance
Summary
The Senior Quality Assurance Specialist demonstrates technical knowledge and expertise (i.e. (documentation, training, compliance, validation, product launch, planning, sterility, etc.), in assignments, projects and other QA aspects. Executes assignments of medium complexity and develops solutions to defined problems for Quality Assurance. He/she may be responsible for coordinating work assignments, training other employees. The QA team consists of fully qualified professional requiring minimal supervision.
Key Duties and Responsibilities
- Develops alternative solutions to problems,
- Collects, reviews and can analyze data.
- May train employees.
- Makes decisions with designated assignments that influence the goals of the department.
- Communicates effectively and quickly at all levels of the organization, supporting the objectives of the department and management decisions.
- Demonstrates strong technical expertise in the Validation of water systems and Process equipment.
- Provide support for investigations pertaining to sterility assurance events to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and remediation plans.
- Follows cGMP and department safety practices
- May perform the following tasks depending on the business unit of assignment: roles such as author, reviewer, administrator or coordinator in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, SAP, SAP Quality Module, Documentation and/or others.
Qualifications:
- B.Sc. in life sciences or related field
- Minimum of 3 years’ relevant experience, or an equivalent combination of education and experience.
- E xperience in a GMP regulated environment.
- Strong knowledge of aseptic operations
- Demonstrated strong technical expertise and ability to adapt to change
- Demonstrated high levels of values and integrity.
- Ability to maintain positive relationships both internally and externally
- Proven ability to influence and negotiate skillfully in difficult situations with internal and external groups.
- Must be able to work independently and in a team.
- Able to multitask within strict deadlines.
- Be proactive in helping to prevent and resolve problems.
- Strong oral and written communication skills and good interpersonal skills
- Must have excellent computer skills with MS Office and Adobe Acrobat.
- Bilingual in French and English preferred
Qualifications:
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