Job Description:
- To create and /or review and update existing SOPs in accordance with internal policy.
- To assist and develop, draft and review SOP's
- Control, issue, reconciliation, and archive of GMP manufacturing documentation including batch manufacturing records and logbooks both manually and electronically. Printing, issuing and reconciliation of labels.
- Perform QA review and approval of validation lifecycle documentation (URS, DQ, IQ, OQ, PQ, PV) protocols and reports.
- Manage and maintain the existing system for continuous efficiency and improvement.
Responsibilities:
Documents, Records and Data Management:
- Drafting and updating of Standard Operation Procedures (SOPs)
- Ensure the correct and timely input of database entries
- Overseeing the entire lifecycle of documents, from their creation and distribution to their eventual archiving.
- Maintains the document archival room Responsible for filing and maintenance of all controlled documents and records
- Checks format and conformance to document templates Implementing version control measures, ensuring that the most up-to-date versions of documents are accessible.
- Addressing and resolving any technical issues related to document access, retrieval or formatting.
- Engaging in ongoing collaboration with different departments to coordinate document-related activities.
- Archiving older documents and efficiently retrieving necessary information when required.
- Provides additional support and assistance on tasks and projects as directed by management Knowledge in management of electronic QMS is an added advantage.
Deviations, Change Control and Audits Management:
- Support deviations (e.g. test OOS, EM excursion) initiation, investigations and root cause analysis for product defects and quality lapses.
- Support change control and CAPA implementation.
- Support internal and external audits/inspections.
Supplier Qualiifcaiton:
- Carry out supplier validation audits remotely or on-site.
- Manage the root cause analysis and corrective actions process of supplier quality issues and Perform on-site supplier visits for investigation.
- Perform requalifacation of suppliers
