Manufacturing Process Specialist
3 days ago
Mandatory Skills:
- Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, GMPs.
- EDMS & Test Management tools.
- Understanding of FDA's recent guidance on transition of CSV to CSA.
Responsibilities:
The ideal candidate will have hands-on experience in Computer System Validation/Quality Compliance in a regulated industry. Strong knowledge of fundamental cGMP concepts and ISO 9001 Standards is required.
Able to develop clear, concise reports. Excellent written and oral communication skills are necessary for this role.
You will be working on complex projects, handling multiple projects, and meeting deadlines. Managing priorities and workflow with versatility and flexibility is essential.
Requirements:
- Hands-on experience in Computer System Validation/Quality Compliance in a FDA Regulated industry.
- Strong knowledge of fundamental cGMP concepts, FDA/EMA regulations, and ISO 9001 Standards.
- Ability to develop clear, concise reports.
- Excellent written and oral communication skills.
- Ability to work on complex projects, handle multiple projects, meet deadlines.
What We Offer:
This role offers the opportunity to work on challenging projects, collaborate with a team, and contribute to the success of the company.
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