Quality Compliance Manager
Piramal Pharma SolutionsSellersville, PA, USjob_description.job_card.variable_days_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionMaintain eQMS platforms and act as a system administrator (e.g. ComplianceWire, TrackWise, Ensur, eBMR, eForms). Training Program Oversee all site training activities and provide guidance and training to end-users. Build training programs working with department heads and SMEs to create and revise training curricula. Document Control Oversee SOP program. Responsible for document management (e.g., Master Batch Record, protocol Review and approve quality system records in Trackwise Compliance Systems Provide guidance and work with stakeholders from various departments for on-time completion of quality system records such as deviations, CAPAs, Change Controls, and training records. Annual Product Review (APRs) Lead QSC review boards such as Deviation Review Board, CAPA Review Board, Change Control Review Board Provide quality systems metrics on weekly, monthly and quarterly basis. Complaint / FAR / Recall management Quality Technical Agreements (QTAs) Supplier Management Program Audit Management Program (Internal, External, Client, and Regulatory Authorities) Data Integrity Program Manage Computer System Validation (CSV) program. Site Data Integrity Compliance Officer (DICO) with responsibility over data integrity program. Support site quality improvement projects and electronic systems implements / updates. Work with corporate quality team for continuous improvement and implementation of Global Policies and Procedures Adhere to set safety standards. Other QSC activities as assigned. Bachelor degree or higher in relevant scientific quality assurance / technical field Ability to organize time and drive project tasks for multiple areas (major projects and daily functions). Good written, verbal and interpersonal communication skills. Basic computer skills such as Microsoft Office 10+ years’ experience in a Manufacturing environment, QA, Quality Systems, and / or Compliance experience in a cGMP / FDA regulated environment with 5 or more years in a supervisor / manager role.
Job Description
Manager Quality Compliance
Job Description
Position Name : Manager Quality Systems & Compliance
Department : Quality Systems
Location : Sellersville, PA
Position Summary : The Manager Quality Systems & Compliance ensures compliance with global regulatory requirements governing the manufacturing, testing, warehousing, and distribution of pharmaceutical drug products at PPL Healthcare LLC - Sellersville. This position will support overall cGMP and regulatory compliance at the site by ensuring that the quality systems are used effectively to support the company quality policy and objectives while driving continuous improvement.
To perform this position successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and / or ability required :
- In depth knowledge of global pharmaceutical regulations (e.g., FDA, EMA, PDMA, ANVISA, TGA, DEA)
- In depth knowledge of Quality Management Systems and Quality Compliance for non-sterile pharmaceutical manufacturing
- Experience with eQMS including DMS, LMS, and eBMR.
- Experience with audit, supplier management, and data integrity.
- Strong teamwork and communication skills
Key Responsibilities
Minimum Education Qualification
Functional or Technical Skills
Minimum Experience (in Years)
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Quality Manager • Sellersville, PA, US
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