Quality Responsible
il y a 2 jours
The Quality Responsible Execute and ensure that each and every one of the processes related to the provision of services agreed with customers are carried out in accordance with the Quality standards established by the Company, being aimed at achieving full customer satisfaction and the regulations of the subsidiaries to which it provides support (Spain/Belgium).
**Responsibilities**:
- Incorporate the company's Quality and Safety standards and/or Policies into the subsidiary's QMS and ensure that the subsidiary's resources receive proper training in the procedures established by the company. Implement the Security System in the subsidiary with the support of the global areas and supplier in terms of security.
- Maintain the Quality Management System in accordance with the standards defined by the company at a global level.
- Verify that the procedures of other areas are available and aligned with regulatory and customer requirements.
- Carry out the correct investigations of claims, deviations and findings and that preventive, corrective and effective actions are proposed that lead to the improvement of the Quality Management System and avoid recurrence of events. It applies to own facilities, clients, processes, local authorities, suppliers (which must be approved under current procedures) and outsourced services.
- Carry out and keep updated on the activities defined by the local authorities.
**REQUIREMENTS**:
- 5+ years’ experience in Regulated pharmaceutical industry and related industry focused on quality operations.
- Must have direct experience with Quality Assurance within the Pharmaceutical industry.
- Knowledge in local laws and regulations.
- Experience with ISO13485, 9001 standards.
- Understands and applies comprehensive knowledge of quality and GMP principles.
- Maintains current understanding of global GMP regulations.
- Familiarity or experience with the following is strongly preferred: Basic statistics, review/approval of documentation; risk tools, technical writing, and Writing/reviewing/approving investigations
- Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.
- Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.
- Demonstrated experience making sound independent decisions.
- Excellent verbal and written communication skills.
- Must be able to read, write, and converse in English fluently.
- Positive work attitude that supports teamwork and continuous improvement.
Pay: €4,000.00 per month
**Benefits**:
- Company car
Schedule:
- Day shift
- Monday to Friday
**Education**:
- Bachelor's (required)
**Experience**:
- Quality assurance: 5 years (required)
**Language**:
- English (required)
Willingness to travel:
- 25% (required)
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