Lead, Quality & Compliance – GMP & Audits

Piramal Pharma Ltd; Ipswich City; On-site; AUD 120,000 - 150,000; Full time

Job summary

Piramal Pharma Solutions in Australia is seeking a Team Lead, Quality & Compliance to supervise the QA/Compliance team and ensure adherence to cGMP. The role requires guiding QA activities, SOP alignment, and supporting regulatory audits.

You will drive data integrity, document control, and continuous improvement in a fast-paced manufacturing environment. The incumbent will review batch records, support audits, and manage QA documentation, while collaborating with production and regulatory teams

Qualifications

• Bachelor’s degree in physical or biological sciences or engineering; chemistry/chemical engineering preferred.
• Minimum eight years in pharmaceutical operations, regulated life sciences, or quality assurance.
• Experience with GMP (21CFR Parts 11, 210, 211; Annex 11; ICH Q7/Q9/Q10) highly desirable.

Responsibilities

• Lead QA & compliance team to ensure cGMP compliance and SOP adherence.
• Review batch production, analytical, and cleaning records for GMP conformance.
• Support internal and external audits and regulatory inspections, including data gathering.
• Maintain document control, master production records, and data integrity initiatives.
• Identify trends, propose corrective actions, and drive continuous quality improvements.

Skills

Organizational skills

Communication skills

Attention to detail

Analytical skills

Independent work

Regulatory experience

Manufacturing quality knowledge

Education

Bachelor’s degree in physical or biological sciences or engineering

Chemistry/Chemical Engineering preferred

Tools

MS Office

Relational Databases

Statistical tools

Job description

Piramal Pharma Solutions in Australia is seeking a Team Lead, Quality & Compliance to supervise the QA/Compliance team and ensure adherence to cGMP. The role requires guiding QA activities, SOP alignment, and supporting regulatory audits.

You will drive data integrity, document control, and continuous improvement in a fast-paced manufacturing environment. The incumbent will review batch records, support audits, and manage QA documentation, while collaborating with production and regulatory teams