About the Role: We are seeking an experienced Project
Manager with a strong background in the pharmaceutical industry,
particularly in validation and change control. The ideal candidate will
be responsible for managing and coordinating multiple projects while ensuring
compliance with regulatory requirements and industry best practices.
Key Responsibilities:
- Oversee
the planning, execution, and completion of validation and change control
projects.
- Develop
and implement project plans, timelines, and resource allocation
strategies.
- Ensure
compliance with GxP regulations, FDA, EMA, and other industry standards.
- Manage change control processes, ensuring that all modifications are
assessed, approved, and documented properly.
- Coordinate
with cross-functional teams, including Quality Assurance (QA),
Regulatory Affairs, Manufacturing, and Engineering.
- Monitor
project progress, identify risks, and implement mitigation strategies.
- Prepare
and present project status reports to stakeholders and senior management.
- Facilitate
validation activities, including IQ, OQ, PQ, and process validation.
- Maintain
documentation and ensure audit readiness.
Qualifications & Experience:
- Bachelor’s/Master’s
degree in Pharmaceutical Sciences, Engineering, Life Sciences, or a
related field.
- Minimum 5-7 years of project management experience in the pharmaceutical
industry.
- Strong
knowledge of validation (process, cleaning, equipment, and computer
systems validation).
- Experience
with change control management systems and regulatory compliance.
- Familiarity
with GMP, FDA, EU regulations, and ICH guidelines.
- Proficiency
in project management tools (MS Project, Jira, Smartsheet, etc.).
- PMP,
PRINCE2, or similar certification is a plus.
- Strong
leadership, communication, and problem-solving skills.
Preferred Skills:
- Experience
in biotechnology, sterile manufacturing, or medical device industries.
- Ability
to work in a fast-paced and regulated environment.
- Knowledge
of risk management and continuous improvement methodologies.
