Quality Assurance Associate – MES

Designation : Associate

Function : Quality Assurance

Functional Area : QA - MES Support

Job Role Summary : Supporting MES Specialists by providing a QA perspective. Verify compliance for activities, quality oversight of DS manufacturing facilities, reviewing real-time investigations, ensuring smooth batch manufacturing, and evaluating practices against defined standards

Job Profile :

• Supporting cross functional team of MES Specialists by providing a QA perspective with regards to DS manufacturing processes, documentation requirements, and overall design of records.
• Accountable for maintaining project timelines associated with quality assurance initiatives.
• Having knowledge and hands on experience on MES application on the aspects of both designing of MBR’s and its execution in order to have a brief understanding on how the recipe (design) functions during execution.
• Reviewing and approving MES recipes, master batch records, and electronic records to meet the requirements of manufacturing and QA users.
• Identifying errors in designs and suggesting alternatives way forwards that are aligned with GMP & compliance.
• Reviewing MES change controls, MES related SOPs, work instructions, forms, Assessment reports & QRA’s.
• Collaborating in the creation, review, and approval of EBR’s with CFT’s.
• Support audits, inspections, investigations and CAPA management related to MES.
• Providing end-user support for MES usage and working closely with IT to troubleshoot problems associated with QA functions.
• Perform assessments of existing procedures/documents to gauge appropriateness for the inclusion of drug substance operations; where current documents are not adequate, identify path forward for establishment of procedures.
• Develop, write, review, and approve SOPs and other documents. This includes documents for operation and facility SOPs, quality training, batch documentation, etc.
• DS QA/ IPQA responsibilities such as support in PCO’s, line clearances, oversight activities, shop floor visit, vial issuances

Job Requirements :

• 4-8  years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)
• A solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.
• In-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.
• Understanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.
• Awareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.

Work / Job Experience : 4-8 Years

Type of Experience : Quality Assurance or Manufacturing experience in Pharma Biologics, Biosimilars

Academic Qualifications :

M.sc (Life Science)  /M Pharm 

Job Post Link : https://tinyurl.com/mrxss9j7