Sr. Manager - Quality Assurance
Hudson Pharma
Karachi
Posted Nov 20, 2025
397
Apply by: Dec 20, 2025
Job Highlights
Job Type
Full Time
Education and Experience:
We are looking for a dynamic and detail-oriented Quality Assurance Lead to oversee all QA activities across manufacturing, packaging, validation, and documentation. This position plays a key role in ensuring regulatory compliance and continuous quality improvement.
Education and Experience Required:
- B.Pharm, Pharm D, or related discipline.
- 5 years of relevant QA experience in pharmaceutical, nutraceutical, or healthcare industry. At least 3 years in a supervisory or managerial role. In-depth knowledge of GMP, GDP, ISO standards, and regulatory requirements (DRAP, ICH, EU, WHO).
Roles and Responsibilities:
- Lead QA functions across manufacturing, packaging, qualification, and documentation.
- Ensure compliance with cGMP, ISO 9001, 14001, 45001, and 17025 standards.
- Review and approve BMRs/BPRs; ensure adherence to product registration dossiers.
- Manage CAPAs, Change Controls, Deviations, and timely closures.
- Handle product complaints, recalls, and market returns with effective root cause analysis.
- Oversee preparation and review of SOPs, protocols, and QA documentation.
- Coordinate with DRAP and regulatory authorities for inspections and responses.
- Lead internal/external audits; ensure audit readiness and CAPA follow-up.
- Manage supplier/vendor qualification and performance.
- Approve product and packaging release in coordination with QC and Warehouse.
- Drive QMS implementation and GMP awareness trainings.
- Oversee implementation of Validation Master Plan and qualification activities.
- Conduct Management Review Meetings and follow-ups.
- Perform additional tasks as assigned by management.
Hudson Pharma
Our mission at Hudson Pharma is to identify molecules that address local patient’s unmet needs across the globe. In developing markets in particular, we look at efficacious molecules that are under-penetrated often with new delivery methods or novel manufacturing processes that vastly improve both safety and attainability.
In our plant in Karachi, Pakistan we produce injectables, oral liquids, and respules in polyethylene containers using the innovative blow fill seal (BFS) process. In addition to our BFS line, we have separate manufacturing lines dedicated for ophthamological and dermatological products. Our activities include developing, contract manufacturing, and marketing branded generic and specialty drugs in the following therapeutic areas: respiratory products, vitamins, dermatological products, diluting agents, anti-inflammatories, anesthetics, anti-infectives, anti-nauseants, anti-emetics, anti-ulcers, NSAIDs, and ophthalmics.
In our plant in Karachi, Pakistan we produce injectables, oral liquids, and respules in polyethylene containers using the innovative blow fill seal (BFS) process. In addition to our BFS line, we have separate manufacturing lines dedicated for ophthamological and dermatological products. Our activities include developing, contract manufacturing, and marketing branded generic and specialty drugs in the following therapeutic areas: respiratory products, vitamins, dermatological products, diluting agents, anti-inflammatories, anesthetics, anti-infectives, anti-nauseants, anti-emetics, anti-ulcers, NSAIDs, and ophthalmics.
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