Piramal Pharma Solutions
Quality and Compliance Specialist
Riverview, USA
Sponsorship not specifiedDetected 24 days ago
ExcelSAPERPGMPFDA RegulatoryResearchCommunicationMicrosoft Office
About the role
- Be the First to Apply Division Piramal Pharma Solutions 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.
Responsibilities
- Support QA administrative duties such as; issuing master production records and appropriate labeling to manufacturing, ensuring that the current version is issued.
- Support maintenance of document tracking systems.
- Support internal and external audits and regulatory inspections.
- 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.
Requirements
- Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
- Perform other related assignments and projects as required.
- 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).
- 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.)
Compensation
- This may include support to Annual Product Reviews, Non-Conforming Material Reports, and Investigation Reports.
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