Senior Mfg QA Specialist: GMP, EM & Audit Lead

Piramal Pharma Ltd; Lexington (KY); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Piramal Pharma Solutions in Lexington is seeking an EXPANSION Sr. Mfg QA Specialist to lead in-process QA activities, environmental monitoring, audits and QMS support under GMP compliance.

This position reports to the QA Supervisor, works on nights, and requires strong regulatory knowledge, detailed documentation, and ability to drive CAPA and investigations across multiple manufacturing campaigns. Responsibilities include modifying SOPs, reviewing batch records, supporting CAPA, and serving as

Qualifications

• Bachelor’s degree in physical or biological sciences preferred.
• 4+ years QA or environmental monitoring in pharma manufacturing.
• Experience with IPQA/EM, cGMP or FDA compliance.
• Strong communication and documentation skills.
• Proficiency with MS Office applications.

Responsabilités

• Oversee in-process QA activities and environmental monitoring per SOPs.
• Review batch records, protocols, and supporting docs to support disposition.
• Lead EM activities for classified areas and maintain lab instrumentation.
• Lead complex GMP investigations including root-cause analysis and CAPA development.
• Serve as SME for Environmental Monitoring, Contamination Control, and Sterility concerns.

Connaissances

QA experience

Environmental monitoring

Regulatory knowledge

MS Office

Communication skills

Detail oriented

Formation

Bachelor's degree in physical or biological sciences

Outils

Microsoft Office

Description du poste

Piramal Pharma Solutions in Lexington is seeking an EXPANSION Sr. Mfg QA Specialist to lead in-process QA activities, environmental monitoring, audits and QMS support under GMP compliance.

This position reports to the QA Supervisor, works on nights, and requires strong regulatory knowledge, detailed documentation, and ability to drive CAPA and investigations across multiple manufacturing campaigns. Responsibilities include modifying SOPs, reviewing batch records, supporting CAPA, and serving as