Ensuring Quality Excellence
il y a 1 jour
The role of Quality Assurance Specialist is to ensure the delivery of safe and effective products to patients by upholding a quality culture that adapts and evolves to meet the needs of patients.
About the Role
This position involves ensuring the application of established quality systems to meet regulatory authority requirements for on-site finished product manufacturing. Key responsibilities include managing, investigating, reviewing, and following on-site quality deviation reports, as well as monitoring and reviewing CAPAs and commitments resulting from investigations.
- Ensure the application of established quality systems to meet regulatory authority requirements for on-site finished product manufacturing.
- Manage, investigate, review and follow on-site quality deviation report's approval
- Monitor and review CAPAs and commitments resulting from investigations
- Conduct regular audits to ensure compliance with regulatory requirements.
Required Skills and Qualifications
To be successful in this role, you will require a Bachelor's + 5 or degree in Pharmacy, Biology, Chemistry, or equivalent field, with experience in pharmaceutical industry / quality assurance or a similar regulated environment. You will also need strong knowledge of GMP, regulatory compliance, and quality systems, as well as excellent analytical, organizational, and communication skills.
- Bachelor's + 5 or Degree in Pharmacy, Biology, Chemistry, or equivalent field
- Experience in pharmaceutical industry / quality assurance or a similar regulated environment
- Strong knowledge of GMP, regulatory compliance, and quality systems
- Excellent analytical, organizational, and communication skills
Preferred Requirements
A bonus point if you have experience at a manufacturing site, managing and writing deviations, or experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management. Additionally, strong problem-solving skills, ability to work independently and as part of a team, and excellent time management and multitasking abilities are highly valued.
- Experience at a manufacturing site
- Managing and writing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management
- Strong problem-solving skills
- Ability to work independently and as part of a team
- Excellent time management and multitasking abilities
Benefits
Pfizer is an equal opportunity employer. We offer competitive salary and benefits package, including medical, dental and vision insurance, retirement savings plan, paid time off, and career development opportunities.
