Job Description:
We are seeking a Qualified Person to report to the Plant Manager.
The ideal candidate will be responsible for supporting direction and management of plant operations for Production, Maintenance, and Quality in the development, scale-up, and technology transfer of products. This includes the production of cGMP products for clinical testing.
The Qualified Person will coordinate plant activities through planning with departmental managers to ensure manufacturing objectives are accomplished in a timely and cost-effective manner. They will establish and monitor overall plant performance for production and quality standards according to GLP and cGMP guidelines.
The successful candidate will provide leadership and training to achieve company goals and objectives. They will also implement and maintain preventative maintenance programs, as well as provide direction, development, and leadership to the Production Manager.
Key Responsibilities:
* Support direction and management of plant operations
* Coordinate plant activities to ensure manufacturing objectives are met
* Establish and monitor overall plant performance for production and quality standards
* Provide leadership and training to achieve company goals and objectives
* Implement and maintain preventative maintenance programs
Ideal Candidate Profile:
We are looking for a candidate with:
* Previous appointment as a Qualified Person of a plant authorized for the production of medicinal substances
* Proven experience with inspections by Competent Authorities for relevant authorizations of drug production and release
* Proven experience in GMP production of proteins or biologics
* At least three years of experience in the Quality Control unit of a plant authorized for the production of medicinal substances
* Excellent scientific writing skills and fluency in English
Requirements:
* Bachelor's degree in a relevant field
* Experience in a pharmaceutical or biotechnology industry
About Us:
We are a leading company in the pharmaceutical industry, dedicated to providing high-quality products and services to our customers.
Contact Information:
Please do not contact us with unsolicited applications. Only qualified candidates will be contacted for an interview.