Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. Our capability as an integrated service provider &

experience with various technologies enables us to serve Innovator and Generic companies worldwide.

Piramal Pharma

Solutions’ HPAPI Research and Manufacturing facility 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 Positive 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. Review of batch production records (including analytical test packages, cleaning records, etc.): 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; File completed batch production records, testing records, and cleaning records.

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. During an audit of ASH, participate in the audit to explain ASH’s quality systems and operations.

Reports/Document Management: This may include support to Annual Product Reviews, Non-Conforming Material Reports, and Investigation 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 in order to reduce the number of deviations/corrections. Assist in effective implementation of data integrity procedures and overall data integrity compliance in Production. Perform other related assignments and projects as required.

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, participating in applicable teams and maintaining Risk Management documents. 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, regulated life sciences, quality assurance, or an equivalent combination of Quality and technical education will also be considered. Strong computer skills with MS Office (e.g. Word, Visio and Excel), Relational Databases, Reporting and statistical tools.

Proficient in TrackWise, SAP and Master Control or experience working with document management and ERP systems. Excellent organizational and planning skills. Have the ability to develop, perform, evaluate, and troubleshoot within a scientific discipline.

Experience interacting with FDA or other regulatory agencies Knowledge with manufacturing quality (manufacturing, packaging, facilities, critical systems, validation, SPC, etc.) Piramal Pharma Solutions is a global CDMO providing comprehensive drug development and manufacturing services, specializing in APIs, clinical supplies, and innovative pharmaceutical solutions. Pharmaceutical Manufacturing Chemical Manufacturing Manufacturing 1500 Bull Lea Rd, Lexington, KY 40511, US 1st Floor, Ananta, Agastya Corporate Park, Opposite Fire Brigade, Kamani Junction, LBS Marg, Kurla (West), Mumbai, Maharashtra 400070, IN 110 Industrial Pkwy N, Aurora, Ontario L4G, CA 18655 Krause St, Riverview, Michigan 48193, US Piramal Pharma Solutions Whalton Road, Morpeth, Northumberland NE61 3YA, GB Piramal Healthcare UK Ltd., Piramal Pharma Solutions, Earls Road, Grangemouth, Stirlingshire, Scotland, UK,, Grangemouth, Stirlingshire, Scotland FK38XG, GB Ennore Express Highway, Ernavoor, Chennai, Tamil Nadu 600057, IN Digwal Village, Kohir Mandal, Medak, District - Andhra Pradesh, Digwal, Telangana 502321, IN Pharmaceutical Special Economic Zone, Village Matoda, Sarkhej-Bawla NH #8A, Taluka Sanand, Dist. Raigad, Plot K -1, Raigad, Maharashtra 402302, IN 650 Cathill Rd, Sellersville, Pennsylvania 18960, US Hemmo Pharmaceuticals Private Limited (Wholly Owned Subsidiary of Piramal Pharma Solutions), Turbhe , Maharashtra 400604, IN Piramal Pharma Solution, MIDC Industrial Area, Rabale, Navi Mumbai, Maharashtra, Navi Mumbai , Maharashtra 400701, IN Piramal Pharma Limited - Development Services, Plot # 19 Pharmaceutical Special Economic Zone (PHARMEZ), Village Matoda, Sarkhej-Bawla NH #8A, Taluka Sanand, Dist.

📌 Regulatory Affairs and Quality Specialist (Riverview)
🏢 Piramal Pharma
📍 Riverview