About Amtera: Amtera is a leading consultancy firm specializing in engineering, technology, and compliance. Our mission is to foster advancement in these fields and provide innovative solutions to our clients across a wide range of sectors, including Biopharma, Pharmaceutical, Chemical, FMCG, Medical Devices, as well as Energy, Banking, and Insurance. At Amtera, we are dedicated to excellence and thrive on delivering impactful results through cutting-edge technology and engineering practices.
Position Overview: We are seeking a meticulous and experienced Documentation Specialist to join our team for a client in the API (Active Pharmaceutical Ingredient) manufacturing industry. This role focuses on the installation phase of a new site, ensuring all documentation is accurate, complete, and compliant with industry standards. The ideal candidate will have a strong background in documentation management within the pharmaceutical or API manufacturing sector.
Key Responsibilities:
- Develop, compile, and manage documentation related to the installation phase of the new API manufacturing site.
- Ensure all documentation complies with industry standards, including GMP, FDA, and EMA regulations.
- Collaborate with engineering, construction, and quality teams to gather and verify documentation requirements.
- Maintain accurate records of equipment installation, commissioning, and qualification activities.
- Prepare and review Standard Operating Procedures (SOPs), work instructions, and other technical documents.
- Ensure timely and accurate documentation of changes and updates throughout the installation process.
- Manage document control processes, ensuring all documents are properly categorized, stored, and easily retrievable.
- Conduct regular audits of documentation to ensure compliance and identify areas for improvement.
- Provide training and support to project teams on documentation standards and procedures.
- Liaise with external contractors and vendors to ensure proper documentation of installation activities.
Key Requirements:
- Bachelor’s degree in a relevant field such as Engineering, Life Sciences, or Information Management.
- Proven experience in documentation management within the pharmaceutical or API manufacturing industry.
- In-depth knowledge of GMP, FDA, EMA, and other relevant industry standards and regulations.
- Strong understanding of the installation and commissioning processes in an API manufacturing environment.
- Excellent attention to detail and organizational skills.
- Strong communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
- Proficiency in document management systems and software.
- Ability to manage multiple tasks and priorities in a fast-paced environment.
- Familiarity with project management principles and practices is a plus.
- Willingness to be on-site as required during the installation phase.
Why Join Us?
- Opportunity to contribute to a high-impact project within the API manufacturing industry.
- Collaborate with a team of experts dedicated to advancing engineering, technology, and compliance.
- Be part of a forward-thinking company that values your professional growth and development.
- Enjoy a dynamic and supportive work environment.
Amtera is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
