Manufacturing Specialist
3 days ago
Planet Pharma is seeking a highly skilled Manufacturing Specialist to support documentation, including drafting and approval of SOPs, Batch Records, Deviations, CAPAs, etc.
Key Responsibilities:- Lead teams investigating minor, major, and critical non-conformances and deviations, including gathering information through structured root cause analysis.
- Own and manage change controls associated with manufacturing areas and equipment.
- Participate in technology transfer, conference calls, and sharing of technical information.
- Coordinate front-end document requests with supporting departments.
- Ensure that Deviations and CAPAs are addressed in a timely manner, and that Batch Records revisions are reviewed and approved in a timely manner.
- Continuously seek and support new approaches, practices, and processes to improve the efficiency and efficacy of document review and revision.
- Adhere to Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs), including Good Documentation Practices (GDP).
- Complete recording of data to comply with regulatory requirements.
- Attend weekly management meetings to discuss timelines and weekly priorities.
- Contribute to projects to ensure timely initiation and completion of work.
- Troubleshoot issues and prioritize workload to solve moderately complex problems, including on-the-floor troubleshooting support as needed.
- Ability to work in a team environment and independently as required.
- Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GMP requirements.
- Review data as generated/collected by less experienced technical staff.
- Must adhere to Planet Pharma's core values, policies, procedures, and business ethics.
- Comply with Safety SOPs, SDS sheets, and laboratory procedures per company policy and OSHA regulations.
- Perform miscellaneous duties as assigned.
***Compensation within this range will be commensurate with level of experience.***
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