Quality Assurance Specialist
6 days ago
The Quality Assurance Specialist plays a vital role in ensuring the quality of products by implementing and maintaining a robust quality system. This involves conducting thorough testing of raw materials, intermediates, APIs, and finished goods to ensure compliance with regulatory requirements.
Key Responsibilities:- Development and validation of analytical methods, including cleaning method validation and associated troubleshooting as required.
- Providing analytical support during technology transfer and process validation phases, including monitoring of production and analytical results.
Responsibilities also include preparation and review of laboratory documentation, such as method transfer and validation protocols, SOPs, calibration procedures, analytical test records, and miscellaneous protocols. Additionally, the specialist conducts stability testing programs in accordance with approved procedures.
Required Skills and Qualifications:- Bachelor's degree in Chemistry or related field.
- Minimum 2-3 years of experience in quality control and analytical laboratory settings.
- Proven expertise in HPLC and GC techniques, with proficiency in data analysis software.
- Strong organizational and communication skills, with ability to prioritize tasks effectively.
This position requires a self-motivated individual who can work independently and collaboratively as part of a team. The ideal candidate will possess a strong passion for quality assurance and a commitment to delivering high-quality results.
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