Job Details
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Job Description
Job Duties and Responsibilities
- Manage the preparation, issue and control of GSP, GDP documents
- ensuring that required standards of presentation and formatting are consistently achieved.
- Aware of implementation ISO 9001,45001,14001 documentation System.
- Format, write, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so.
- Perform the Business System Administration role in the documentation management system.
- Ensure that all document training and distribution are carried out as required.
- Maintain document control software packages including; controlled documents database.
- Develop and maintain the document archiving system.
- Scan and photocopying of controlled documents.
- Provision of training to personnel and contract personnel as directed by the Quality Manager.
- Assist implementation of procedures, SOPs and policies into the Quality Systems.
- To actively support the development/implementation and continuous improvement of the Document Management System and supporting systems.
- Provide support for regulatory submissions through collation and compilation of documents for inclusion in filings or presentation to auditors as required.
- Review the batch records.
Job Requirements
Education:
- Bachelor degree in pharmacy.
Experience, Skills & Competencies:
- Check the storage condition in the warehouse.
- Check the implementation of SOP and work instructions.
- Internal Auditor for GSP, GDP and ISO 9001.
- Create new SOPs according to the international standards and customer requirements.
- Check and approve the return products.
- Implement a training plan for the warehouse employee.
- Follow up the corrective actions.
- Issue change control.
- Check the FIFO process in the warehouse.
- Document controller.
Excellent Communication skills , time management and Hard-worker
