Quality Assurance Compliance Specialist

About the role

The Quality & Compliance Specialist (QA) position at Piramal Pharma Solutions' HPAPI Research and Manufacturing facility in Riverview, Michigan, supports the manufacturing operations of the 24x7 facility. The role focuses on ensuring compliance with regulatory requirements set by the USFDA and other international regulatory authorities.

Responsibilities

• Review of batch production records (including analytical test packages, cleaning records, etc.): Ensure batches meet GMP requirements and are manufactured according to approved SOPs, and resolve batches pending approval due to GMP errors and related corrective action investigations.
• Operations Support: Walk the production areas to promote adherence to GMPs, address corrections or deviations in real-time, and review batch-related data in real-time during shifts.
• Administrative Duties: Support QA administrative tasks such as issuing master production records, ensuring current versions are issued, filing batch production records, testing records, and cleaning records, and maintaining document tracking systems.
• Audits: Support internal and external audits and regulatory inspections, conduct internal audits, and participate in the development of responses to audit reports.
• Reports/Document Management: Support Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports, prepare and review associated documentation, and perform trend analysis for metrics reporting.
• Quality Systems Support: Ensure compliance with internal procedures, participate in continuous initiatives, and assist in implementing data integrity procedures.
• Risk Management: Participate in the Risk Management program, update risk analyses, and maintain Risk Management documents.

Requirements

• Bachelor’s degree in the physical or biological sciences or engineering with 1 or more years’ experience in pharmaceutical operations/quality or another GMP environment.
• Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, or quality assurance.
• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).
• Strong computer skills with MS Office (Word, Visio, Excel), relational databases, reporting, and statistical tools.
• Proficient in TrackWise, SAP, and Master Control or experience with document management and ERP systems.

Competencies

• Excellent organizational and planning skills.
• Strong written, verbal, and interpersonal communication skills.
• Strong attention to detail orientation.
• Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
• Demonstrated strong analytical skills, and the ability to work independently against multiple deadlines.
• Experience interacting with FDA or other regulatory agencies.
• Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.).