What are the responsibilities and job description for the Compliance Analyst position at Planet Pharma?
Job Responsibilities
Education and Experience
- Manage and resolve technical and compliance issues with Quality, Technology, Maintenance, Facilities, Calibration & EH&S.
- 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
- Ensure maintenance of a safe manufacturing work environment that complies with company and state regulations.
- 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
Education and Experience
- BS/BA in Life Sciences/Engineering preferred, and at least 5 years experience in the pharmaceutical, biopharmaceutical industry or a combination of education and experience.
- Ability to make sound decisions about scheduling, allocation of resources and managing of priorities.
- Direct experience with mammalian cell culture and/or purification of biopharmaceutical products
- 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
- Environment requires that gowning in the form of hospital scrubs, bunny suits, gloves and steel toe boots be worn.
- 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.
Salary : $40 - $50