What are the responsibilities and job description for the Quality Assurance Engineer position at Harba Solutions Inc.?
Job Responsibilities:
- Lead the development, implementation, and upkeep of the site's quality management systems and associated procedures.
- Review and authorize documents related to changes in processes or products, including Change Control and Process Management.
- Serve as a key point of contact for regulatory bodies like the FDA during on-site audits.
- Approve and assess validation documents, requirement specifications, SOPs, and data integrity evaluations.
- Gather, evaluate, and report on quality system data to ensure compliance, track trends, and identify areas for improvement.
- Conduct audits of quality systems and propose corrective actions based on findings.
- Develop and refine procedures, conduct statistical evaluations, and address system remediation needs.
- Thrive in a fast-paced and dynamic environment with a flexible mindset.
- Foster effective communication and positive relationships with diverse internal and external stakeholders.
- Promote a safe, compliant working environment through training, awareness, and adherence to safety guidelines and SOPs.
- Oversee the upkeep of department facilities and equipment.
- May involve additional responsibilities such as developing specifications, SOPs, providing quality system training, and participating in Quality Review Board meetings.
- Ensure compliance with US and international regulatory standards (e.g., FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP).
- Devise creative solutions to complex problems in alignment with organizational goals.
- Advise management on ways to enhance operational practices and technologies.
Qualifications:
- A Bachelor's degree in Biology, Chemistry, Life Sciences, or a related field is required.
- At least 8 years of relevant experience in Quality or Validation within a pharmaceutical manufacturing environment, with extensive knowledge of quality systems.
- Proven experience in supporting inspections conducted by regulatory authorities.
- Solid background in investigating deviations and variances.
- In-depth knowledge of regulatory guidelines for establishing, validating, and documenting test procedures, equipment, processes, and facility systems.
- Familiarity with cGMP guidelines and their implementation in aseptic environments.
- Ability to collaborate effectively with cross-functional teams to resolve issues and ensure compliant outcomes.
- Proficiency in statistical tools and Microsoft Office suite.
Salary : $70,000 - $85,000
