Quality Assurance Manager at Orange Drugs

Duties and Responsibilities

• To take disposition on finished goods.
• To evaluate batch record
• To prepare Annual Product Review
• To assist in solving the quality problems.
• To manage complaints and give solutions concerning quality.
• To ensure that the appropriate validations are done. The validation consists of Machinery validation (IQ, OQ, PQ), HVAC Validation (IQ, OQ, PQ), Cleaning Validation and Process Validation.
• Prepare Validation master plan
• To ensure that self-inspection and/or quality audit which regularly appraises the effectiveness and applicability of the quality assurance system are done.
• To manage GMP, GLP and all other management systems applied by Orange Kalbe Ltd Nigeria.
• To do Calibration of instrument
• To conduct Vendor qualification and audit
• Quality Risk Management implementation
• Consumer/product recall based on mock recall practice
• Stability study for routine and new product development
• Manage the deviation report and change control
• Manage proper documentation (valid SOP, Batch record, validation data)
• Manage the training plan and execution.

Qualifications

• Bachelor's Degree in Pharmacy (Pharmacist)
• Have experiences in pharmaceutical factory in production, minimum of 5 years or as QA manager, minimum of 3 years
• Understand and comprehend quality management system
• Have good computer literacy.

Remuneration
To be Discussed.