API Quality Assurance Role
The API EM Quality Assurance Specialist provides critical support to all quality activities at Contract Manufacturing organizations (CMs).
Serving as a liaison between CMs and company, this role ensures seamless communication and collaboration.
Key responsibilities include providing quality oversight of CMs, evaluating and disposing API batches if required, and ensuring compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
Maintaining awareness of external regulatory agency findings that reference the quality of the product is also crucial.
This position involves reviewing and approving various documents, including procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods, and computerized system validations.
Key Objectives:
1. Liaise between CMs and company to facilitate smooth operations.
2. Provide quality oversight of CMs to ensure adherence to standards.
3. Evaluate and dispose API batches as needed to maintain product quality.
4. Ensure compliance to Quality Agreements and MRDs for optimal results.
Requirements:
* Bachelor's degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
* Previous experience in GMP manufacturing, QC, QA, or Engineering, preferably in API or finished product manufacturing.
Preferred Qualifications:
* Experience supporting quality control activities for CMs.
* In-depth technical understanding of quality systems and regulatory requirements.
Education Requirements:
* Bachelor's degree in a science-related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.