
Chief Quality Assurance Officer
6 days ago
As a key member of our quality assurance team, you will play a vital role in ensuring that our products meet the highest standards of quality and safety.
The successful candidate will have a strong background in quality control and testing, with a deep understanding of regulatory requirements and industry standards. They will be responsible for implementing quality management systems, conducting audits and inspections, and collaborating with cross-functional teams to drive process improvements.
We are looking for someone who is passionate about delivering high-quality products and services, and who has a proven track record of driving results in a fast-paced environment.
Responsibilities- Ensure compliance with local regulations, GMP, and global policies.
- Authorize final release or rejection of finished products as per SOPs and Drug Act requirements.
- Establish, maintain, and monitor the Quality Management System (QMS) and related procedures.
- Approve executed batch records and certify production batches before release.
- Implement product quality and validation plans to ensure robust manufacturing and packaging processes.
- Conduct internal audits, support GMP audit programs, and oversee inspection/testing plans.
- Ensure effective deviation handling, CAPA, and change control processes.
- Review and approve Annual Product Reviews (APR) with corrective action plans.
- Monitor adherence to quality control procedures during every production step.
- Investigate customer complaints and identify preventive measures to avoid reoccurrence.
- Maintain batch history records, finished product/raw material samples, and quality documentation.
- Analyze quality data, track KPIs, and implement process improvements.
- Collaborate with supply and regulatory teams to uphold QA culture and standards.
- Ensure smooth transition of NPD/EPD projects into manufacturing operations.
- Lead and develop QA teams while fostering a positive, compliance-driven culture.
- Doctor of Pharmacy (Pharm-D) or Bachelor's in Pharmacy (minimum requirement).
- At least 7 years overall, with a minimum of 5 years in quality control and testing of drugs.
- Preferred Qualification*: MBA/MPhil or equivalent business-related degree for added leadership and management exposure.
- Strong understanding of product safety, quality, efficacy, and compliance risks.
- Regulatory Knowledge: Clear knowledge of relevant regulations such as Drug Act 1976, DRAP Rules 2012, ISO standards, and ICH guidelines
- Commercial Awareness
- Business Partnership
- Collaboration
- Partnership building
- Ability to challenge the status quo
- Propose improvement
- Accountability
- Adaptability
- Collaborator
- R&D
- Product Lifecycle Management
We value diversity, equity, and inclusion, and welcome applicants from diverse backgrounds. We offer competitive compensation and benefits packages, as well as opportunities for professional growth and development.
Equality We recognize that great people don't always fit one mold. If this role and our organization feel like a good fit for you, we encourage you to apply.
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