Document Control Specialist
PERFORMANCE LABS PTE. LTD.
S$3000 - S$3500
The primary purpose of the Document Control Specialist is to ensure the Document Control System across all platforms is fully operational and ensures the integrity of document creation, version control, storage, retrieval, and lifecycle management are effectively implemented. Ensure Document Management is consistent across the organization while maintaining control and traceability of the documentation history in compliance with 21 CFR part 111 (FDA).
Essential Duties and Responsibilities
- Initial main responsibility will be to oversee and ensure successful implementation of a new QMS for Document Control and Training for Unicity, in conjunction with external QMS and multidisciplinary Unicity staff.
- Responsible for managing the creation, revision, and retiring of all controlled documents; including but not limited to specifications, routers, SOP’s, work instructions, forms, templates, and policies.
- Support the commercialization of new products in executing the creation of routers in the Quality Management and ERP system.
- Responsible for managing the Change Control Board and Impact Assessment surrounding facility, equipment, software, processes, customer specifications, controlled documents and procedural changes.
- Maintain the Document Management Systems in QMS.
- Ensure document numbering, formats, issuance, review, revisions, dispatch, recording and archiving follow 21 CFR 111 regulations.
- Responsible for the integrity of the data entered into the Quality Management System.
- Responsible for identifying process improvement opportunities throughout the change control process.
- Maintain and manage electronic and hard copy documents as required.
- Collaborate with Product Development, Acct. MGMT, R&D and OPS to ensure control and timing of documentation and data in alignment with business needs.
- Assist in the preparation of validation of changes throughout the company and issue of reports as required.
- Develop, standardize and monitor technical documents review, approval and implementation in accordance with agreed schedule with other departments.
- Produce project management status reports as needed.
- Assist with Audits and inspections.
- General document control activities such as photocopying, scanning, and filing as needed.
- Assist with cross-training of Document Control personnel and customers to ensure adherence with procedures.
- Other responsibilities and tasks assigned by management
- Bachelor’s Degree in Biology, Food Science, or related field preferred.
- Minimum 3 years related experience and/or training; or equivalent combination of education and experience.
- Experience in Network-based system, Quality Management Systems Software (QMS) & QAD.
- Experience with ETQ QMS preferred.
- Excellent verbal and written communication skills.
- Experience in creation, review, and approval of manufacturing specifications.
- Knowledge of 21 CFR regulations.
- Positive can-do attitude.
- Independent and resourceful, able to multi-task and excel in a collaborative global environment.
- Ideally have experience in working across languages and cultures.
- Experience in delivering effective communication through various channels and mediums.
- Meticulous and possess a keen sense to detail.
- Ability to work on a strategic and tactical level.
- Skilled in professional and effective presentation of products
- Strong adaptability and a desire to pursue and grow your career in a dynamic working environment.
Closing on 02 Oct 2021