Senior QA Compliance Specialist - GMP, CAPA & Audits

Piramal Pharma Ltd; Bethlehem (Northampton County); On-site; USD 90,000 - 130,000; Full time

Job summary

Piramal Pharma Ltd is seeking a Senior Quality Assurance Compliance Specialist to oversee daily quality activities, ensuring GMP and regulatory compliance. Responsibilities include document control, CoA approval, and CAPA/change control coordination.

Qualifications require a BS in science/QA and 5+ years in pharma QA, with strong cGMP knowledge and cross-functional collaboration. The role supports regulatory audits and quality systems, including eDMS/document workflows.

Qualifications

• Bachelor’s degree in a scientific, quality assurance, or technical field.
• Minimum 5+ years of relevant pharmaceutical QA experience.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Strong cross-functional communication across different levels of the organization.
• Expertise in Quality systems and tools.
• Proficiency in Microsoft Outlook, Excel, Word, and other web-based systems.
• Strong understanding of computer system validation and GAMP requirements.

Responsibilities

• Review, approve, and disposition finished products and provide final Certificate of Analysis (CoA) approval.
• Coordinate investigation and closure of non-conformances, ensuring CAPA and change controls are initiated and completed.
• Lead or participate in cross-functional deviation investigations and improvement projects.
• Review and approve laboratory investigations, ensuring root cause identification.
• Support QA team members and assist in departmental training.
• Provide support during regulatory audits.
• Maintain and revise document control procedures.

Skills

Critical thinking

Communication skills

Verbal & written communication

Detail-oriented

Organizational skills

Data analysis

Regulatory knowledge

Process improvement

Education

Bachelor's degree in science/QA

Tools

Microsoft Outlook

Excel

Word

Job description

Piramal Pharma Ltd is seeking a Senior Quality Assurance Compliance Specialist to oversee daily quality activities, ensuring GMP and regulatory compliance. Responsibilities include document control, CoA approval, and CAPA/change control coordination.

Qualifications require a BS in science/QA and 5+ years in pharma QA, with strong cGMP knowledge and cross-functional collaboration. The role supports regulatory audits and quality systems, including eDMS/document workflows.