Manufacturing Documentation Specialist
3 days ago
About the Role:
We are seeking a highly skilled Manufacturing Documentation Specialist to join our team at Planet Pharma. As a key member of our manufacturing operations team, you will be responsible for ensuring the accuracy and completeness of documentation related to our biopharmaceutical manufacturing processes.
Key Responsibilities:
- Support the development and maintenance of Standard Operating Procedures (SOPs), Batch Records, and other manufacturing-related documents.
- Lead investigations into deviations and non-conformances, and ensure timely resolution and documentation.
- Manage change controls and procedural updates to ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
- Collaborate with cross-functional teams to ensure seamless execution of manufacturing processes and documentation.
- Ensure accurate and complete documentation of manufacturing activities, including data collection and record-keeping.
Requirements:
- Minimum 2 years of experience in biopharmaceutical manufacturing operations, with a focus on documentation and quality assurance.
- Strong knowledge of GMP regulations and industry standards.
- Excellent communication and interpersonal skills, with the ability to work effectively in a team environment.
- Ability to analyze complex data and identify areas for improvement.
- Proficiency in Microsoft Office and other relevant software applications.
Working Conditions:
- This role will work in a cleanroom environment, with exposure to biohazards, human blood components, and chemicals.
- Able to work in a fast-paced environment with multiple priorities and deadlines.
What We Offer:
- Competitive salary and bonus structure.
- Opportunities for professional growth and development.
- A dynamic and collaborative work environment.
How to Apply:
Interested candidates should submit their resume and a cover letter outlining their qualifications and experience.
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