Quality Assurance Specialist
7 days ago
In this role, you will be responsible for designing and implementing validation procedures to ensure the quality and consistency of pharmaceutical products. You will work closely with cross-functional teams to develop and execute qualification and validation plans.
About Quanta Consultancy Services Ltd
We are a leading consultancy specializing in pharmaceutical manufacturing and process validation. Our clients value our expertise and commitment to delivering high-quality solutions.
Responsibilities
- Design and author qualification and validation documentation, including standard operating procedures (SOPs) and change control procedures.
- Develop and execute execution plans for cycle development and performance qualification activities.
- Collaborate with production, maintenance, and quality representatives to resolve technical issues during study execution.
- Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
- Perform root cause analysis of system failures using standard tools and methods.
- Suggest improvements through Lean Six Sigma methodologies.
Requirements
- A degree in applied pharmaceutical or biological sciences, engineering, or a related field.
- Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers.
- Exception/Deviation Management and Change Control experience.
- Leading technical projects is essential.
- Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.
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