Job Description

Quality Assurance Associate
In line with current Good Manufacturing Practices (cGMP), the Quality Assurance Associate is entrusted with carrying out a diverse range of assignments within the Quality Assurance department.
Responsibilities and roles:

• -Collaborate with the Production team to review executed Production Records.
• -Provide QA support for manufacturing processes on the production floor.
• -Review SOPs, logbooks, and related documentation associated with daily QA activities.
• -Conduct internal audits of GMP operations to ensure compliance.
• Investigate quality events by performing a thorough root cause analysis, plan science-based hypothesis testing, develop an effective Corrective and Preventive Action (CAPA) plan, and prepare a comprehensive report.
• Review test records, raw data, and documents according to company procedures, data integrity and adherence to specifications. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture.
• Collect and analyze laboratory data for the monitoring and evaluation of product quality and complaint trends.
• Author technical reports (i.e., annual product quality review, audit reports), evaluate trends and escalate adverse trends to management.
• Provide QA oversight of facilities, warehouse, production areas, and laboratories.

 

• -Offer assistance during external regulatory or partner GMP audits.
• -Develop and implement improvements to quality system procedures.

Qualifications:

• Bachelor's Degree and at least three year of QA experience in the pharmaceutical bio industry
• Excellent communication (verbal and written), interpersonal, and teamwork skills
• Ability to be productive and successful in a fast-paced work environment
• Preferred Additional Capabilities
• Prior experience in the CDMO industry
• Experience working with GMP compliant / quality-controlled procedures
• Multilingual

 

Job Tags

Full time,

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