Proclinical are recruiting for a Validation Manager to join a biotech organisation. This role is on a permanent basis and is located in Amsterdam.
- Serve as a representative for the division at cross functional meetings as the crucial shareholder for all process engineering and calibration linked subjects.
- Assist the production and upkeep of validation program documents and SOPs.
- Uphold team metrics linked to on-time distribution and offer regular status updates to management.
- Conduct objective setting and period performance evaluations of direct reports in line with business goals.
- You will balance workload of and motivate direct reports and/or contract personnel to achieve divisional objectives and targets.
- Handle protocol production, implementation assistance, data analysis, report production and approval for multiple installation, operational and performance qualification actions.
- Guarantee performance of all qualification actions is rendering to internal processes, industry and regulatory leadership.
- Other duties may be assigned.
Key Skills and Requirements:
- Educated to a degree level in a life science or engineering field.
- Demonstrable experience within qualification/validation of utilities, equipment, and procedure in assistance of parenteral pharmaceutical or biopharmaceutical product manufacturing.
- Exhibited experience managing teams.
- Expertise on regulatory needs such as EMA, FDA, etc., as well as industry guidance core competencies such as ISPE, PDA, etc.
- Familiarity in various areas of validation, which involves: Commissioning; Equipment and Utility Qualification; Computerized System Validation; Environmental Qualification; Sterilization Validation; Requalification, etc.
- Leadership and interpersonal abilities.
- Works well in a team.
- Able to work on various tasks simultaneously as well as conduct assignments that have loosely outlined goals which need investigation of different variables.
- Capable of implementing expertise on various engineering fields to review and develop solutions for operational concerns.
- Ability to plan, arrange, conduct and document work while under minimal supervision.
- Computer literacy.
If you are having difficulty in applying or if you have any questions, please contact Dominic Williams at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.