Quality & Compliance Team Lead — GMP & Audits

Piramal Pharma Limited; Town of Riverview (WI); Sur place; USD 110 000 - 140 000; Plein temps

Résumé du poste

Piramal Pharma Solutions is seeking a Team Lead, Quality & Compliance to oversee the QA team and ensure cGMP compliance across operations. The role ensures SOPs and regulatory requirements are followed and supports continuous improvement.

Responsibilities include reviewing batch records, supporting audits, maintaining document control, and providing training. Strong knowledge of GMP, TrackWise, SAP and Master Control is valued to drive data integrity and compliant manufacturing.

Qualifications

• Bachelor's degree in physical/biological sciences or engineering.
• 8+ years' experience in pharmaceutical operations, regulated life sciences, or quality assurance.
• 2-5 years of supervisory experience.
• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).

Responsabilités

• Review batch production records to ensure GMP compliance and SOP conformance.
• Walk production areas to reinforce GMP and address deviations in real time.
• Assist QA administrative duties including labeling and document tracking.
• Support internal/external audits and regulatory inspections.
• Prepare and review Analytical Methods Validation, Cleaning Validation and Process Validation docs.
• Support data integrity initiatives and track quality metrics.
• Train ASH Stevens team members and maintain QA training files.

Connaissances

Organizational skills

Communication

Attention to detail

Analytical skills

FDA interactions

Manufacturing quality

Formation

Bachelor's degree in physical/biological sciences or engineering

Chemistry/Chemical Engineering preferred

Outils

TrackWise

SAP

MasterControl

Description du poste

Piramal Pharma Solutions is seeking a Team Lead, Quality & Compliance to oversee the QA team and ensure cGMP compliance across operations. The role ensures SOPs and regulatory requirements are followed and supports continuous improvement.

Responsibilities include reviewing batch records, supporting audits, maintaining document control, and providing training. Strong knowledge of GMP, TrackWise, SAP and Master Control is valued to drive data integrity and compliant manufacturing.