SRG West Yorkshire, England, United Kingdom
Senior Validation Specialist
1 week ago Be among the first 25 applicants
Salary: Highly competitive basic salary, bonuses & benefits!
SRG is exclusively working with a global pharmaceutical company who require a QA Validation Supervisor to join their well-established Quality Assurance Validation team, supervising a team of 4 responsible for QA Validation activities, as required.
The successfully QA Validation Lead will ensure validation studies and activities are planned and executed in line with company SOPs and GMP Requirements and Regulations, supporting the validation manager with management of the validation team.
Responsibilities:
* Writing, executing and reviewing validation protocols in accordance with procedural requirements and current regulatory standards.
* Writing and reviewing validation reports ensuring outcome of protocol objectives are documented.
* Ensuring Validation Incident reports are raised, investigated with resolutions in place and closed in a timely manner.
* Act as a deputy to line manager and supervise as required.
* Lead and author risk assessment, FMEA and other root cause analysis techniques to provide appropriate information on product and processes. Ability to identify suitable mitigations and actions.
* Ensures validation is in accordance with the SVMP and Regulations. Maintains a good knowledge of updates to regulations and ensures standard procedures are updated in accordance with changes to the regulations.
* Leads the execution of validation activities. Ensures all validation deliverables are met within agreed project timescales.
* Monitors and reports delivery of key Quality Organisation Metrics in relation to Validation activities.
* Providing guidance with process improvement projects and Tech Transfer of new products ensuring the process and cleaning validation is performed in line with procedural and regulatory requirements.
* Develop and implement systems that will improve validation activities and work efficiencies.
Requirements:
* Extensive recent experience in a leadership role within a GMP Quality Assurance Validation environment, preferably Cleaning Validation activities.
* Line Management Experience within a quality assurance/validation team in a GMP environment.
* Proved track record of leading pharmaceutical validation projects across cross functional teams.
Seniority level:
Mid-Senior level
Employment type:
Full-time
Job function:
Quality Assurance
Industries:
Pharmaceutical Manufacturing
#J-18808-Ljbffr