Operations Document Controller

Job Overview:

To plan and control the activities of microbiology department while ensuring deliverables meet defined quality standards and all connected activities are in compliance with in-house procedures and cGMPs.

Responsibilities

1. Responsible for management of document room including labelling and arrangement of files, storage, issuance, and retrieval on approved request.

2. Shall be responsible for identifying, retrieval, movement, and control of documents during external audits.

3. Creation and control of uncontrolled documents for external circulations or sharing as approved by authorized QA personnel.

4. Stamping, copying and document control of documents generated at site such as SOP, specifications, test procedures, validation protocols etc. including issuance, retrieval, archival, destruction etc.

5. Issuance of batch manufacturing and packaging record to production department as per request.

6. Archival and retrieval of batch documents as and when required.

7. Shall support QA staff for routine operations

8. Shall be responsible for movement of sample from manufacturing to QC.

9. Filing of training records in individual training files in document cell.

10. Responsible for issuance, retrieval and archival of logbooks.

11. Ensure confidentiality of information.

12. Maintaining data integrity in all record keeping activities.

Desired Qualifications and Experience:

1. Proven work experience as a Document Controller or similar role for about 3 to 5 years in Life Science Industry.

2. Familiarity with project management, for e.g. MS Projects.

3. Well versed with MS Office, MS Excel and power point.

4. Knowledge of Electronic Document Management Systems (EDMS).

5. Proficient typing and editing skills.

6. Data organization skills.

7. Good communication skills, fluent in English, both written and spoken