Job Description:
The Document Officer is responsible for controlling, maintaining, and managing GMP documentation related to solid dosage form manufacturing. This role ensures compliance with regulatory requirements, data integrity principles, and internal SOPs. The position also supports manufacturing operations through cross-training across multiple production areas to enhance flexibility and operational coverage.
Key Responsibilities:
- Prepare, review, issue, control, and archive GMP documents, including but not limited to:
- Standard Operating Procedures (SOPs)
- Batch Manufacturing Records (BMR) / Batch Packaging Records (BPR)
- Specifications
- Logbooks
- Validation and qualification documents
- Ensure proper document version control, numbering, approval status, and effective dates.
- Ensure timely issuance and retrieval of documents for production and quality activities.
- Support document reconciliation and reviewing in Batch manufacturing & packing manufacturing.
- Coordinate with Production and Quality Assurance to resolve documentation discrepancies or gaps.
- In accordance with the production plan, the employees shall receive training to operate the machines.
Operational Support
- Participate in cross-training across manufacturing processes including Dispensing, Blending, Encapsulation, Coating, and Packing to support production flexibility and continuity.
Qualifications:
- Diploma in Pharmacy.
- Fresh graduates may be considered for junior or entry-level roles.
Skills & Competencies:
- Knowledge of GMP and pharmaceutical documentation practices.
- Strong attention to detail and organizational skills.
- Ability to manage multiple documents and priorities effectively.
- Good communication and coordination skills.
- Basic understanding of data integrity requirements.
How to Apply: Please email your CV to hr@awamedica.com and include the job title in the subject line.
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