Senior QA Compliance Lead - GMP & Regulatory Excellence

Piramal Pharma Limited; Bethlehem; On-site; GBP 65,000 - 90,000; Full time

Job summary

Piramal Critical Care, a unit of Piramal Pharma, seeks a Senior Quality Assurance Compliance Specialist to oversee daily QA activities and ensure GMP/regulatory compliance. You will manage documentation control, CoA approvals, and support during audits.

Responsibilities include leading CAPA investigations, non-conformance closures, and cross-functional improvements. Strong knowledge of cGMP, QA systems, and computer validation is essential for success in this role.

Qualifications

• Bachelor’s degree in a scientific, quality assurance, or technical field.
• Minimum 5+ years of relevant experience.
• Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
• Strong cross-functional communication skills 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.
• Facilitate client project management to ensure quality deliverables are completed on time and in full.
• 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.
• Review BOMs, inspection plans, calibration records, and SOPs.
• Perform internal audits and assist in audit report preparation.
• Maintain and revise QA procedures.

Skills

Quality systems

Regulatory compliance

Documentation control

CAPA

Change controls

Data analysis

Auditing

Education

Bachelor’s degree in a scientific, quality assurance, or technical field

Tools

Microsoft Outlook

Excel

Word

eDMS

Job description

Piramal Critical Care, a unit of Piramal Pharma, seeks a Senior Quality Assurance Compliance Specialist to oversee daily QA activities and ensure GMP/regulatory compliance. You will manage documentation control, CoA approvals, and support during audits.

Responsibilities include leading CAPA investigations, non-conformance closures, and cross-functional improvements. Strong knowledge of cGMP, QA systems, and computer validation is essential for success in this role.