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The Document Management Assistant will assist in management of production batch records, GMP documentation and electronic systems associated with the site production teams.
* Routing of new and revised procedures/ batch records and compliance documents in Quality Docs documentation management system
* File documents in physical and digital records and ensure appropriate storage.
* Liaise with internal stakeholders to track and retrieve issued documents for timely return. Preparing these documents for archive
* Review and maintain the accuracy of the records, editing where necessary to ensure they are up to date
* Management of regulatory documents, ensuring their accuracy, quality and integrity and compliance with version control
* Upload documents in line with site SOP’s – appropriate templates used etc.
* Supporting Data Integrity- specifically the issuing, controlling and reconciling of procedural attachments.
* Track documentation errors and highlight common problem areas.
* Maintain confidentiality around sensitive documentation
* Assist on internal and external audits
* Ad-hoc tasks – ordering stationary, maintaining printers, or any other tasks related to supporting the Document Control team
Requirements:
* A minimum of 3 years of experience working in a fast-paced, administrative role
* Strong interpersonal and communication skills with a willingness to help others.
* Proven ability to deal with unexpected issues using a problem-solving skill.
* Proven interest in working within pharmaceutical production and understanding our business processes.
* Demonstrated Good Documentation Practices and compliance with procedures.
* Self-motivation with the ability to operate without close supervision.
* Strong IT skills: Proficiency in the Microsoft Office Suite, experience with Document Management Systems, PDF Software File naming and version control, basic troubleshooting, database entry, workflow configurations.
* Experience with ISO Standards will be an advantage.
* A Bachelor's degree is preferred; however, a Level 6 diploma in a relevant field is required.
Support Considerations:
Working hours : 39 hours / week. Monday to Friday & occasionally some non-scheduled call-in time to respond to operational support issues.
What would you bring?
As a valued team member, you'll play a crucial role in delivering customized BPO solutions, ensuring our clients achieve consistent high performance and meet their strategic objectives. Your expertise will contribute to our legacy of success in providing outsourced solutions for Fortune 500 companies.
Ready to be a part of our dynamic team? Explore exciting opportunities with Covalen – where your skills, ideas, and achievements are celebrated!
Equal opportunity employer:
At Covalen, we champion diversity and equality, anchoring our workplace cultures and creative minds. We recognize the collective strength found in the diverse backgrounds, skills, and experiences of our team members. Our commitment to fostering an inclusive environment transcends gender, marital status, family status, age, disability, sexual orientation, race, religion, and membership in the Travelling community.
For more information, don't hesitate to reach out fatema.aziz@covalensolutions.com your journey to becoming a valued part of Covalen starts here.
Apply Now or Reach Out for More Information.
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Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Administrative
* Industries
Outsourcing and Offshoring Consulting, Pharmaceutical Manufacturing, and Information Services
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