Detalles de la oferta

Job Description Project Manager to lead and manage projects in the aseptic areas, particularly in the development, validation, and FDA submission processes for pharmaceutical and medical device products.
Responsibilities: Develop project timelines, resource allocation plans, and budgets, ensuring timely and on-budget delivery.
Coordinate and oversee all stages of project execution from design, development, and validation through to FDA submission.
Lead and manage complex projects related to the development, commissioning, process development and validation of aseptic pharmaceutical or medical device products.
Ensure compliance with FDA and other regulatory bodies' requirements, particularly in aseptic areas and sterile manufacturing processes.
Prepare and review documentation for FDA submissions and other regulatory filings.
Work closely with internal stakeholders (R&D, quality assurance, operations, regulatory affairs, etc.)
to ensure cross-functional alignment and timely execution of project milestones.
Manage risk assessments and mitigation strategies to address project challenges.
Conduct periodic project reviews and provide status reports to senior management, highlighting key project milestones, risks, and issues.
Requirements Bachelor's degree in Engineering, Life Sciences, or a related field (Master's degree preferred).
8+ years of experience in project management in a regulated pharmaceutical, biotechnology, or medical device industry, with a focus on aseptic areas and FDA submissions.
PMP certified preferable.
Proven track record of leading projects through FDA submissions.
Strong knowledge of FDA regulations (CFR Part 210/211, 21 CFR Part 820), aseptic processing, validation protocols, and good manufacturing practices (GMP).
Experience with process validation, cleaning validation, and equipment qualification in aseptic manufacturing.


Salario Nominal: A convenir

Fuente: Talent_Ppc

Requisitos

Qc Project Manager

Job Description QC Project Manager with experience in regulated industry.   Duties: Manage projects related to laboratory testing, method validation, and equ...


Qrc Group, Llc - Caguas

Publicado 22 days ago

Qa Project Manager

Job Description QA Project Manager with experience in regulated industry. Duties: Oversee projects focused on implementation of digital and AI solutions that...


Qrc Group, Llc - Caguas

Publicado 21 days ago

E-Commerce Manager

• Oversee a team of designers and opertations staff • Responsible for all online activities • Develop affiliate marketing programs • Create and maintain an o...


Caribbean Retail Ventures - Caguas

Publicado 19 days ago

Qa Project Manager

Oversee projects focused on implementation of digital and AI solutions that drive process performance and enhance operational excellence. Lead initiatives re...


Qrc Group Llc - Caguas

Publicado 13 days ago

Built at: 2025-02-07T04:44:14.646Z