Quality Assurance Associate – MES
Job summary
We are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves quality oversight of DS manufacturing facilities, reviewing real-time investigations, ensuring smooth batch manufacturing, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.
Roles & Responsibilities
- Expertise in 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.
- Working with Technical Trainers to develop QA training plans for MES users.
- Provide mentorship during on-the-floor manufacturing
- DS QA/ IPQA responsibilities such as support in PCO’s, line clearances, oversight activities, shop floor visit, vial issuances
Educational qualification: M.sc (Life Science) /M Pharm
Minimum work experience: 4-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)
Skills & attributes:
Technical Skills
• 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.
• Comprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.
• Ability to understand and implement organizational policies and ensuring compliance.
Behavioural skills
• Demonstrates a commitment to continuous learning.
• Strong communicating and influencing skills.
• Displays analytical and logical thinking abilities.
• Is self-motivated and takes initiative.
• Adaptability to the work environment, along with being a team player.
• Ability to go beyond boundaries, showcasing a proactive and innovative approach.
Ability to work in shifts
ABAC
