- Assist in managing 3rd Party CMO Quality activities including but not limited to CMO audits, Quality Agreements, Change Controls, Deviations, CAPA and aid Supply Chain / Commercial for timely delivery of products.
- The candidate will assist in FDA inspections as needed at Avet.
- This position requires a candidate to carry out quality functions at Avet as needed and assist Associate Director – External Supply Quality.
- The candidate will assist in handling all customer service inquiries, sales and marketing queries from quality standpoint and help facilitate the required document to support commercial quality function.
- The candidate will handle all the quality activities pertaining to repackaging outsourced by Avet and ensure that there is quality agreement in place to handle such quality activities.
- This position has no direct reports.
- Create, review and revise quality agreements with CMOs, API vendors, Avet customers and re-packagers covering products manufactured at CMOs for distribution in United States.
- Responsible for all quality activities pertaining to repackaging process such as primary packaging components assessment, review of change controls and batch records (master executed) and stability requirements.
- Assist in market actions such as product withdrawal and product recall process including initiation, periodic updates, effectiveness checks, destruction & termination of the recall.
- Maintain complete product list covering CMO, raw materials manufacturer and any other vendors subject to audits covering products manufactured at CMOs for distribution in United States. Assist in management of vendor audits scheduled and perform audits as required.
- Assist in submitting required notifications to Regulatory Agencies such as FAR, Drug notification, DEA forms as applicable to each specific case and track subsequent follow-up submissions till closure.
- Track all corrective actions proposed as a result of FDA inspection of CMOs impacting Avet / Emcure products. Assist in review and tracking of QMS documents such as change controls, deviations, OOS, complaints, APQR and batch records reviews till closure.
- Review batch release documents per written procedure.
- Coordinate preparation of quality management review meeting presentations within external supply quality team and CMOs to have required information on routine basis.
- Provide product safety data sheet documents to Avet customer service team. Coordinate between CMOs and Avet/Emcure quality teams to resolve customer service inquiries such as product related information, documents and handling of returned products at Avet’s third party warehouse.
- Any additional tasks as assigned by the supervisor supporting external supply quality function.
Specialized Skills and Knowledge:
- Bachelor’s in science discipline such as biological sciences, microbiology, biochemistry, pharmaceutical science etc. Masters is preferred.
- Minimum 3 years’ experience in pharmaceutical Quality systems, Quality Control, R&D and or Compliance functions involving pharmaceutical products manufacturing, packaging, testing, and distribution.
- Must have excellent written and verbal English skills.
- Must be able to work individually on assigned projects with very minimal guidance and work cross-functional teams at Avet / Emcure and globally with different CMOs for above listed job functions.
- Experience of working in the CMO space, handling CMOs, auditing pharmaceutical components / products manufacturing facilities for cGMP compliance preferred.
- Preferred working knowledge of electronic systems to manage quality functions in pharmaceutical industry.
- Advanced level computer skills in Microsoft Word, PowerPoint and Excel.
Work is primarily sedentary in nature; routine bending, walking, lifting and reaching are required. Frequent Local and International traveling required for audits and compliance initiatives.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Avet is proud to be an Equal Opportunity Employer.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs