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Piramal Pharma Ltd · 4 months ago

Manager Quality Systems & Compliance

Sellersville, PA

Full-time

Onsite

Senior Level, Lead/Staff

10+ years exp

Piramal Pharma Ltd is a company focused on pharmaceutical solutions, and they are seeking a Manager Quality Systems & Compliance to ensure compliance with global regulatory requirements. This role involves maintaining quality systems, overseeing training programs, and managing compliance systems to support the company's quality objectives.

BiotechnologyConsumer GoodsHealth CareManufacturingPharmaceutical

Responsibilities

Maintain eQMS platforms and act as a system administrator (e.g. ComplianceWire, TrackWise, Ensur, eBMR, eForms)

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

Oversee SOP program

Responsible for document management (e.g., Master Batch Record, protocol

Review and approve quality system records in Trackwise

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

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)

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

Qualification

Global pharmaceutical regulationsQuality Management SystemsEQMS experienceAudit managementSupplier managementBasic computer skillsTeamwork skillsCommunication skills

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

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

Company

Piramal Pharma Ltd

Piramal Pharma Limited (PPL) offers a portfolio of differentiated products and services through its 17 global facilities, which include end-to-end development and manufacturing capabilities, and a distribution network in over 100 countries.

Founded in 2020

Mumbai, Maharashtra, IND

10001+ employees