123pracovat

Pracovní nabídka

Job Mission:

Ensure compliance with regulatory requirements and the standards of the company at all the stages of product manufacturing in Kourim facility. Plan and supervise the development and implementation of the Quality System, regulatory standards and procedures consistent with customer expectations and business goals of the organization. Manage the Groups of Quality Assurance and Quality Control towards common goals of quality.

Knowledge of cGMP practices and 21 CFR part 111, 100, 117 standards that are customary within the applicable industry and mandated by government regulations. Common standards managers are expected to be familiar with the Hazard Analysis and Critical Control Points (HACCP) management system required by the Food and Drug Administration (FDA) and the standards set by the Safe Quality Food Institute (SQFI).

Responsibilities

• Managing the QA and QC groups to ensure both efficient operation and the highest standards of compliance with regulatory requirements.
• Ensures implementation and maintenance of Global Quality Standards.
• Liaise with internal groups to ensure compliance with Regulatory requirements.
• Responsible for the assurance of the Quality of the products manufactured in the site.
• Review and approval of Instruction manuals, warning labels and product specification for product sent for 3rd party testing or any “New” to company products
• Review, tests and approves of all licensed products prior to production or 3rd party testing
• Directs internal or 3rd party laboratory testing required for licensed products.
• Review and direct corrective action for any failures found during internal or 3rd party testing to overseas offices.
• Writes Corrective Action Plans (CAPS) for any 3rd party testing failures.
• Writes testing and inspection protocols used for 3rd party inspections.
• Working with clients to ensure that their Quality Agreements are approved in a regular basis and they are met.
• Leading the preparation and execution of Regulatory Inspections at the site.
• Responsible for the conduct and timely execution of assigned International Quality Assurance projects at Kourim site, QA resource optimization strategies for global projects where possible. Facilitate efficient resource utilization.
• Instill a culture of continuous improvement.

We expect:

• University degree in Biotechnology, Chemistry or related subject
• Minimum 8 years of working experience in Quality Assurance in a pharmaceutical, biotechnology environment. Excellent Pharma cGMP knowledge .
• Supervisory/management experience
• Good written and oral communication skills in English, knowledge of Czech
• Coaching and developing people skills; strong communication, technical writing, organizational and interpersonal skills
• Demonstrates critical thinking skills in problem solving and decision making