QC Asst. Manager (Pharmacist license)

Key Responsibilities:

1. Product & Method Development
- Oversee quality control activities for new pharmaceutical products, ensuring timely execution aligned with company objectives.
- Lead the development and improvement of analytical methods for raw materials, in-process materials, and finished products.
- Ensure analytical method validation and stability studies are conducted in compliance with regulatory standards and internal requirements.
- Prepare and review analytical monographs, specifications, and reports (method validation, stability study, cost evaluation).

2. Regulatory Compliance & Documentation
- Prepare and submit ACTD documents for new product registration, variations, or renewals to the FDA in accordance with timelines.
- Maintain up-to-date documentation, including SOPs, specifications, protocols, and regulatory submissions.
- Support compliance with GMP, GLP, ISO9001, and ISO/IEC 17025 standards.

3. Laboratory & Resource Management
- Manage laboratory resources, including personnel and equipment, to ensure efficient workflow and timely support for new product development.
- Supervise the qualification, calibration, and maintenance of laboratory instruments.
- Control laboratory supplies, inventory levels, and usage cost for consumable materials.

4. Quality & Operational Oversight
- Review and approve analytical reports, certificates of analysis, finished product specifications, and testing documentation.
- Coordinate with third-party laboratories and principals for inter-laboratory comparisons and proficiency testing.
- Monitor stability protocols and ensure scheduled stability testing is completed on time.
- Act as delegate for the QC Department Manager in their absence.

5. Team & Performance Management
- Supervise and evaluate staff performance, recommend hiring, suspension, or dismissal when necessary.
- Monitor team performance and recommend improvements in analysis efficiency and lead time.
- Support team development and ensure personnel follow safety and company policies.

Qualifications:
- Bachelors degree or higher in Pharmaceutical Sciences.
- Minimum 5 years of experience in Quality Control with expertise in analytical method development and validation.
- 5-10 years of experience in pharmaceutical or healthcare manufacturing.
- Strong knowledge of Analytical Method Validation (AMV) is highly preferred.
- Familiar with Thai FDA regulations, PIC/S GMP, and ICH guidelines.
- Excellent understanding of pharmaceutical testing requirements and quality systems.