Job highlights
Control). Strong experience in writing ,implementing, and maintaining SOPs quality documents. Ability to analyze ,research ,and report independently across diverse topics.

The Quality Assurance Associate plays a vital role in ensuring adherence to Good Clinical

Key skills
Medical devices,Data analysis,Manager Quality Assurance,Pharma,Quality systems,Consulting,Clinical trials,Clinical research,Healthcare,GMP
Job description
What you’ll do
Job Summary:

The Quality Assurance Associate plays a vital role in ensuring adherence to Good Clinical
Practice (GCP), Standard Operating Procedures (SOPs), regulatory requirements, and
company policies in clinical trials. This position is responsible for supporting QA processes,
conducting audits, and assisting in risk management to uphold high-quality standards in clinical
research.

Key Responsibilities:
Quality Process Maintenance Improvement:
Maintain and enhance quality processes to ensure compliance with GMP, GDP, and
GCP standards.
Collaborate with cross-functional teams to manage change controls, CAPA, deviations,
complaints, and internal audit follow-ups.
Investigate GxP non-compliances and customer product quality complaints.
Utilize quality tools and techniques to perform root cause investigations and resolve
quality issues.
Compliance Documentation:
Develop and implement corrective and preventive action (CAPA) plans to address
non-conformances.
Update, maintain, and improve QMS process documents.
Perform data analysis, prepare quality trend reports, and communicate insights to
internal stakeholders.
Oversee product specification creation and control.
Conduct Product Quality Reviews (PQRs) as required.

Regulatory Quality Assurance:
Ensure regulatory compliance in distribution supply chain operations for commercial drug
products.
Support GMP/GDP service providers in maintaining post-approval compliance.
Implement Standard Operating Procedures (SOPs) and oversee their adherence.
Provide QA support to pharmacovigilance and regulatory departments.

Skills Competencies:

Essential:
Strong knowledge of GMP and GDP operational quality systems.
Experience in pharmaceutical or life sciences organizations.
Familiarity with quality system processes (e.g., Audits, Deviations, CAPA, Change
Control).
Strong experience in writing, implementing, and maintaining SOPs quality documents.
Ability to analyze, research, and report independently across diverse topics.
Excellent organizational and communication skills.
Strong attention to detail and ability to work under pressure.
Ability to work autonomously and prioritize tasks effectively.
Flexible and adaptable to changing business needs.

Desirable:
Experience managing communications projects (graphics, online, video, etc.) and
working with creative contractors.
Native or fluent English proficiency
Degree in a relevant scientific discipline (e.g., Pharmaceutical Sciences, Life Sciences,
Chemistry, or related fields).
An inquisitive mindset with a proactive approach to problem-solving and continuous
improvement.
Industry type
Clinical Research / Contract Research
Department
Quality Assurance
Role
Quality Assurance – Other
Role category
Quality Assurance – Other
Employment type
Full Time, Permanent
Education
Any Graduate, Any Postgraduate