Job Details
Posted 1 May, 2026
Job Id: 627648
Compliance Analyst
Job Description
Job Responsibilities
* Solve a wide range of difficult issues that impact multiple functions following cGMP regulations and internal standards by applying advanced theory, technical principals and expert judgment.
* Troubleshoot and direct the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnership.
* Provide technical assessments for controlled document changes. Review and approve Change Requests. Participate with discrepancy investigations as well as interact with interdepartmental contacts ensuring discrepancy identification, definition, assessment and resolution.
* Be able to act as SME to regulatory agencies
* Identify the technical, procedural and equipment issues that may compromise production and compliance, working closely with cross-functional groups to identify and implement solutions.
* Implement and follow through on corrective and preventative actions (CAPA) in accordance with timelines.
* Ensure that all operations are performed with 100% compliance to documentation cGMP
Standards.
* Evaluate data, resolve complex problems, and provide input to investigations to Out of Action Limits related to manufacturing clean rooms.
* Manage project teams to troubleshoot and proactively minimize potential for microbial contamination in the manufacturing clean rooms.
* Oversee the manufacturing input for the prompt closure of Adverse Trends through corrective action implementation.
* Lead and and/or facilitate Root Cause Analysis sessions for more complex issues
* Act as the Discrepancy Owner Lead by
* Execute discrepancy ownership tasks while maintaining compliance with GSP009, cGMPs and supporting department/site goals
* Identify and assign initial assessments, attend triage and review assessments
* Summarize deviations and route to QA for closure to support site cycle time goal
* Identify, create and track to closure tracking actions related to deviation resolution
Job Requirements
Education and Experience
* Ability to make sound decisions about scheduling, allocation of resources and managing of priorities.
Knowledge, Skills and Abilities
* Strong oral and written communication skills.
* Ability to make sound decisions with minimal supervision.
* Possess thorough knowledge and understanding of cGMPs and familiarity with FDA, ICH and European guidelines.
* Have proficiency with the following software: Microsoft Word, Excel, and Project.
* Manage assignments that are complex in nature where independent action and a high degree of initiative are required in resolving problems and developing recommendations.
* Experience in technical writing, such as, creation and revision of Standard Operating Procedures or other technical reports/evaluations is desirable
Work Environment/Physical Demands/Safety Considerations
* Some Work in clean room environment with large mechanical equipment, piping, and pumps connecting to tanks serviced by high-pressure steam, water and air together this creates a load environment.
* May work with hazardous materials.
Equal Opportunity Employer
We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert
Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
