Pharmaceutical QC Specialist
5 days ago
Key Responsibilities:
1. Manage the Quality Control Laboratory, ensuring compliance with regulatory standards.
2. Approve or reject raw materials, packing materials, semi-finished products, and finished products based on agreed-upon specifications.
3. Review and approve analytical reports, validation protocols, calibration reports, environmental monitoring plans, and other microbiology laboratory documents.
4. Develop and implement departmental SOPs related to quality control and microbiology laboratories.
5. Ensure instruments are calibrated timely and review their records.
6. Validate analysts for required testing.
7. Manage reference and working standards.
8. Ensure compliance with laboratory instruments and procedures as per 21 CFR part 210, 211 EU GMP, and other applicable GLP regulations.
9. Participate in the investigation of complaints related to product quality.
10. Engage in management reviews of product quality, QMS, and continuous improvement.
Required Skills and Qualifications:
- Strong background in quality assurance and laboratory management
- Excellent analytical and problem-solving skills
- Effective communication and interpersonal skills
- Ability to work in a team environment
- Familiarity with SAP software
- Bachelor's or Master's degree in a relevant field such as chemistry or pharmacy
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