- Initiate the change control process by gathering information and presenting it to the committee for approval.
- Collaborate with technical experts to ensure all stakeholders are engaged in assessing changes.
- Ensure that change controls are meticulously documented for regulatory audits.
- Manage a variety of change controls including new equipment introductions and process modifications.
- Present change controls in review board meetings.
- Assess and communicate the impact of changes on regulatory submissions.
- Apply GMP principles to maintain compliance across all processes.
- Negotiate with QA partners and manage task timelines effectively.
- Identify and escalate any risks during change control execution.
- 5-8 years experience in GMP environment, preferably in biotech/pharmaceuticals.
- Proficiency in writing change controls within electronic Quality Management Systems.
- Experience with tech transfer processes and cGMP requirements.
- Strong written communication skills and ability to simplify complex processes.
- Ability to interpret technical documents and regulatory filings.
- Demonstrated problem-solving and conflict resolution abilities.
Technical Operations Change Control Specialist - Boston, United States - DPS Group Global
Description
Summary
Arcadis DPS is seeking a Technical Operations Change Controls Specialist for a client in Boston, MA.
Key Responsibilities
Skills & Qualifications
Additional
To excel in this role, the individual must continuously seek learning opportunities and contribute to a culture of excellence and teamwork. Customer service, planning, organizing, teamwork, and technological proficiency are essential for success.
The Company
Arcadis DPS Group is a global EPCM firm specializing in Life Sciences and Advanced Technology industries. They are committed to delivering successful projects with a 'client-first' approach across various sectors.
Arcadis DPS Group is an Equal Opportunity Employer focusing on merit, qualifications, and abilities in employment decisions.