Key Responsibilities:
Regulatory Compliance:
- Ensure compliance with cGMP, WHO-GMP, and other regulatory requirements.
Audits:
- Conduct internal, vendor, and external audits to ensure adherence to quality standards.
Documentation Management:
- Prepare, review, and maintain Standard Operating Procedures (SOPs), Master Formula Records (MFRs), Batch Manufacturing Records (BMRs), and validation protocols.
Quality Management Systems:
- Manage change control, deviations, and CAPA (Corrective and Preventive Actions) activities.
In-Process Quality Checks:
- Conduct in-process quality checks during production activities to ensure product quality.
Process Validation:
- Ensure that manufacturing processes are validated and meet predefined specifications.
Training:
- Conduct training sessions for production and quality staff on quality standards and procedures.
Continuous Improvement:
- Identify and implement continuous improvement initiatives to enhance product quality and operational efficiency.
Equipment Qualification:
- Assist in equipment qualification (IQ, OQ, PQ) and process validation activities.
Key Requirements:
- Bachelor’s degree in Pharmacy.
- One month of implant training in the Quality Assurance department.
- Basic proficiency in Microsoft Office.
- Authentic communication, behavior, and actions.
- Ability to manage professional and procedural ambiguity.
- Courageous and soundly confident.
- Flexibility and adaptability.
- Hardworking with strong prioritization skills.
- Mandatory registration with the Pharmacy Council.
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