CQ Specialist Pharmaceutical Manati PR
Aviso de fuente externaen Legal PM Partners (LPMP)
Contract C&Q Specialist supporting pharmaceutical manufacturing, qualification protocols, validation, and CSV activities.
Salario
No especificado
Ubicación
Vega Baja, Puerto Rico
Tipo de empleo
Tiempo completo
Modalidad
No especificado
CQ Specialist Pharmaceutical Manati PR
Vega Baja, Puerto Rico
Descripción del empleo
About the role
Legal PM Partners (LPMP) is seeking a Commissioning & Qualification (C&Q) Specialist to support pharmaceutical manufacturing facilities. This contract-based opportunity is for an independent professional.
The role supports commissioning, qualification, validation, CSV, and implementation activities for pharmaceutical equipment, utilities, computerized systems, and manufacturing areas, in accordance with regulatory requirements and company standards.
Responsibilities
- Develop and execute commissioning, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) protocols for pharmaceutical equipment, utilities, facilities, and manufacturing systems.
- Develop, review, and execute electronic qualification protocols and test scripts using applicable electronic validation or lifecycle management systems.
- Support and document computerized system validation (CSV) activities for computerized, automated, and manufacturing systems.
- Support CSV lifecycle activities, including requirements, risk assessments, test execution, deviation and discrepancy management, traceability, and validation documentation.
- Use and maintain electronic lifecycle management or ALM systems, when applicable, for protocol execution, test management, requirements traceability, documentation, and validation records.
- Ensure qualification and validation activities comply with company procedures and regulatory requirements.
Requirements
- Strong hands-on C&Q experience, including protocol development and execution and equipment and system qualification.
- Exposure to CSV, electronic protocols, and electronic lifecycle management systems such as ALM.
Datos clave
- Contract-based opportunity for an independent professional.
- Supports pharmaceutical manufacturing facilities in the North Area of Puerto Rico (Barceloneta / Manatí).
- The role includes commissioning, qualification, validation, and CSV activities.
- Requires hands-on C&Q experience and exposure to CSV, electronic protocols, and ALM.
Preguntas frecuentes
What does the role involve?
It supports commissioning, qualification, validation, CSV, and implementation activities for pharmaceutical equipment, utilities, computerized systems, and manufacturing areas.
What experience is sought?
The ideal candidate has hands-on C&Q experience, including protocol development and execution and equipment and system qualification, as well as exposure to CSV, electronic protocols, and ALM.
What type of opportunity is this?
It is a contract-based opportunity for an independent professional.