Clinical Systems IT Validation Manager
Clinical Systems IT Validation Manager
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5-7years
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Our client a global pharmaceutical company is seeking a clinical systems validation manager to set strategy and policies and oversight of the Validation Department and programs of related activities.
Job Description:
- Manage staff and workload of the validation team. Provide coaching training and mentoring for routine and complex activities
- Development and implementation of strategy and policies related to validation.
- Development and oversight of the execution of validation related documents throughout the system including development of a comprehensive validation master plan covering equipment utilities sterilization cleaning aseptic processing cleanroom qualification and computerized system validation
- Support change control investigations and MBR s and SOP s updates
- Determine levels of importance or risk to be assigned to elements under review to ensure validation efforts are directed at the systems which have the potential to impact product quality efficacy and data integrity using a variety of tools
- Represent the validation group and defend policies program and validation documentation during audits regulatory inspections
- Develop and coapprove GxP documents including but not limited to Master Validation Plans SOPs IQs OQs PQs protocols and forms to improve validation efficiencies
- Is knowledgeable and complies with all pertinent safety policies rules and regulations
- Ensure that all team members comply with safety rules and regulations
- Maintenance of quality systems and GxP compliance for the business by ensuring that all team members comply with processes procedures and instructions for all activities in which the team participates
- Collaborate with cross functional team members and meet deadlines for various valid
Requirements
- At least 5 years experience Validation Management experience ideally within the clinical medical laboratory or pharmaceutical industry
- Good understanding and application of GMP and regulatory requirements
- Experience of wide range of validations including Computer Systems Validation equipment cleaning and utility and facilities validation plans
- Excellent communication skills
- Previously managed or supervised a team of experienced engineers in a similar industry
At least 5 years experience Validation Management experience ideally within the clinical, medical, laboratory or pharmaceutical industry Good understanding and application of GMP and regulatory requirements Experience of wide range of validations including Computer Systems Validation, equipment, cleaning and utility and facilities validation plans Excellent communication skills Previously managed or supervised a team of experienced engineers in a similar industry
Employment Type
Remote
Company Industry
Key Skills
- Clerical
- Abinitio
- Chiller
- Application Engineering
- ELV
- AV
