Quality and Compliance Specialist

Piramal Pharma Ltd•Riverview, MI

4d•Onsite

About The Position

Piramal Pharma Solutions’ HPAPI Research and Manufacturing facility, Ash Stevens, LLC, in Riverview, Michigan, is seeking a Quality and Compliance Specialist to join its Quality Assurance team. The role supports manufacturing operations at a 24x7 facility and is focused on implementing, executing, and maintaining manufacturing-related Quality Systems so the site complies with USFDA and other international regulatory requirements. Assignments include material release and reviewing and implementing documentation in support of site Quality Systems and GMP operations. The position supports clinical and commercial manufacturing and process development. It is shift-based and requires willingness to work weekends and holidays as needed on a rotating schedule.

Requirements

Bachelor’s degree in physical or biological sciences or engineering and at least 1 year of experience in pharmaceutical operations/quality or another GMP environment; or an associate’s degree and at least 2 years of experience in pharmaceutical operations, regulated life sciences, or quality assurance.
Candidates without a degree may be considered with at least 3–5 years of experience in pharmaceutical operations, regulated life sciences, or quality assurance, or an equivalent combination of Quality and technical education.
Knowledge of GMP requirements, including 21 CFR Parts 11, 210, and 211, Annex 11, and ICH Q7, Q9, and Q10.
Strong computer skills with MS Office, including Word, Visio, and Excel, as well as relational databases, reporting, and statistical tools.
Proficiency in TrackWise, SAP, and MasterControl, or experience working with document management and ERP systems.
Excellent organizational and planning skills.
Strong written, verbal, and interpersonal communication skills.
Strong attention to detail.
Ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.
Strong analytical skills and ability to work independently against multiple deadlines.
Ability to complete tasks independently and notify a supervisor about decisions outside established processes.
Willingness to work a shift-based schedule, including weekends and holidays as needed on a rotating schedule.

Nice To Haves

Experience interacting with the FDA or other regulatory agencies.
Knowledge of manufacturing quality, including manufacturing, packaging, facilities, critical systems, validation, and SPC.

Responsibilities

Review batch production records, analytical test packages, cleaning records, and related documentation to ensure batches meet GMP requirements and are manufactured according to approved SOPs.
Resolve issues involving batches pending approval due to GMP errors and related corrective action investigations.
Review in-process and finished-product batch records and intermediate analytical records; release intermediate products when specifications are met and associated documentation is complete.
Walk production areas to promote and ensure adherence to current GMP, address corrections and deviations with production staff in real time, and explain their impact and prevention.
Review production-generated batch data in real time, including executed batch records, temperature recordings, cleaning records, in-process checks, equipment status tags, and logbooks, for accuracy, completeness, and data integrity compliance.
Issue master production records and appropriate manufacturing labels, ensuring current versions are used; file completed batch, testing, and cleaning records; and support document-tracking systems.
Support internal and external audits and regulatory inspections through data gathering, interviews, or auditor escorting; conduct internal audits, housekeeping inspections, and walkthroughs; document audit findings and follow up on corrective actions.
Participate in audits by explaining Ash Stevens’ quality systems and operations, and contribute to formal responses to audit reports as appropriate.
Support Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports; prepare or review Analytical Methods Validation, Cleaning Validation, and Process Validation reports.
Ensure generated data complies with approved internal procedures and support continuous improvement initiatives related to production and quality.
Provide operational or systems information to internal and external clients as requested; identify trends in batch deviations and corrections and propose corrective actions to reduce them.
Assist with implementation of data-integrity procedures and compliance in Production, and perform other related assignments and projects.
Prepare routine and ad hoc Quality Systems metrics and analysis, including trend analysis in support of management review.
Participate in the Risk Management program, including updating risk analyses, participating in applicable teams, and maintaining Risk Management documents.