Quality and Compliance Specialist

Piramal Pharma Limited; Riverview (MI); On-site; USD 70,000 - 110,000; Full time

Job summary

Piramal Pharma Solutions – Ash Stevens, LLC in Riverview, Michigan is seeking a Quality & Compliance Specialist to support GMP manufacturing operations. You will review batch records, support audits, maintain quality systems, and drive regulatory compliance for USFDA and international authorities.

Strong data integrity and documentation skills are essential. The role involves shift-based work, including weekends/holidays as needed, and collaboration with QA and production teams to ensure product

Qualifications

• Bachelor’s degree in physical or biological sciences or engineering with 1+ year of GMP operations/quality experience.
• Associate’s degree with 2+ years in pharmaceutical operations or quality assurance.
• 3–5 years of pharma operations/regulated life sciences experience accepted in lieu of degree.

Responsibilities

• Review batch production records and analytical test packages to ensure GMP conformance.
• Support internal and external audits and regulatory inspections.
• Maintain document tracking systems and master production records.
• Provide data and reports for quality metrics and management review.
• Participate in risk management activities and data integrity initiatives.
• Assist in investigations, CAPA, and deviation handling.

Skills

GMP knowledge

TrackWise

SAP

MasterControl

Data integrity

Regulatory knowledge

MS Office

Analytical skills

Communication

Auditing

Education

Bachelor’s degree in physical or biological sciences or engineering

Associate’s degree with 2+ years of pharma operations/QA

3–5 years experience in pharmaceutical operations/regulated life sciences

Tools

TrackWise

SAP

MasterControl

Job description

Quality and Compliance SpecialistJob DescriptionPiramal Pharma Solutions’ HPAPI Research and Manufacturing facility (Ash Stevens, LLC), located in Riverview, Michigan, is seeking a qualified Quality & Compliance Specialist (QA) to join our Quality Assurance (QA) team. This Quality Compliance Specialist opening will have an emphasis on supporting the manufacturing operations of our 24x7 facility. The Specialist will directly support the implementation, execution, and maintenance of Quality Systems related to manufacturing to ensure the PPS-Riverview site complies with regulatory requirements as propagated by the United States Food and Drug Administration (USFDA) and other international regulatory authorities. Principle assignments related to compliance may include material release, review and implementation of new and revised documentation to support PPS-Riverview Quality Systems and operations to meet Good Manufacturing Process (GMP) requirements. The scope of this position will support both clinical and commercial manufacturing, as well as process development, in the Riverview facility. This is a shift-based position; the selected candidate must be willing to work weekends, and holidays as needed on a rotating schedule.KEY RESPONSIBILITIES.• Review of batch production records (including analytical test packages, cleaning records, etc.): The incumbent’s primary responsibility will be to ensure that batches meet GMP requirements and are manufactured according to approved Standard Operating Procedures (SOP), and appropriate resolution to batches pending approval due to GMP errors and related corrective action investigations. Review in-process batch records, finished product batch records and intermediate analytical records. Release intermediate products, based upon conformance with specifications and completion of associated documents.• Operations Support: Actively walk the production areas to promote and ensure current Good Manufacturing Practices are being adhered to. In real time address any corrections or deviations with production staff explaining the impact and how to avoid the error moving forward. Review all batch related data generated by the Production team in real time during the shift, including but not limited to executed batch records, temperature recordings, cleaning records, In-process checks, equipment status tags and logbooks for accuracy, completeness and compliance to data integrity.• Administrative Duties: Support QA administrative duties such as; issuing master production records and appropriate labeling to manufacturing, ensuring that the current version is issued. File completed batch production records, testing records, and cleaning records. Support maintenance of document tracking systems.• Audits: Support internal and external audits and regulatory inspections. This may require data gathering, interviewing or escorting auditors during an audit. Conduct internal audits and housekeeping inspections and walkthrough’s of site Quality Systems and related operations to ensure compliance with written procedures. Audits quality system and records, creating documentation as needed. Follow-up as appropriate to ensure corrective action is implemented. During an audit of ASH, participate in the audit to explain ASH’s quality systems and operations. The incumbent is expected to represent ASH’s systems thoroughly and positively,being receptive to the auditor’s comments. Participate in the development of a formal response to audit reportas appropriate.• Reports/Document Management: This may include support to Annual Product Reviews, Non-ConformingMaterial Reports, and Investigation Reports. Participate in preparation or review of associated documentation,such as Analytical Methods Validation Reports, Cleaning Validation Reports, and Process Validation Reports.• Quality Systems Support: Ensure compliance with internal approved procedures of all generated data.Participate in the implementation of continuous initiatives as they relate to production and quality activities.Provide data and information pertaining to operations or systems for internal or external clients as requested.Identify trends from batches that are associated with deviations/corrections and present corrective actions inorder to reduce the number of deviations/corrections. Assist in effective implementation of data integrityprocedures and overall data integrity compliance in Production. Perform other related assignments andprojects as required.• Metrics: Perform routine and adhoc Quality Systems Metric Reporting and analysis for the local site data.Prepare metrics and perform trend analysis in support of management review.• Risk Management: Participate in the Risk Management program, including updating risk analysis, participatingin applicable teams and maintaining Risk Management documents. EDUCATION/EXPERIENCE.• Bachelor’s degree in the physical or biological sciences or engineering with 1 or more years’ experience inpharmaceutical operations/quality or another GMP environment.• Associate’s degree with 2 or more years’ experience in pharmaceutical operations, regulated life sciences, orquality assurance.• Individuals without a degree but having at least 3-5 years’ experience in pharmaceutical operations, regulatedlife sciences, quality assurance, or an equivalent combination of Quality and technical education will also beconsidered.• Knowledge of GMP requirements (21CFR Parts 11, 210, 211, Annex 11 and ICH Q7, Q9 & Q10).• Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting andstatistical tools.• Proficient in TrackWise, SAP and Master Control or experience working with document management and ERPsystems.JOB COMPETENCIES.• Excellent organizational and planning skills.• Strong written, verbal, and interpersonal communication skills.• Strong attention to detail orientation.• Have the 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.)• Must complete tasks independently and notify supervisor of decisions outside of established processes.