
Senior Quality Assurance Manager
2 days ago
Job Title:
Senior Quality Assurance Manager">Job Description:
The Senior Quality Assurance Manager will be responsible for overseeing the development and implementation of quality procedures, ensuring compliance with regulatory guidelines.
Key Responsibilities:
- To handle day-to-day changes, deviations, incidents, market complaints, OOS, OOT in a timely manner.
- Develop second-line personnel through training and evaluation.
- Coordinate with R&D, production, engineering, RA, purchase, compliance, marketing etc. for a robust system.
- Ensure analytical tech-transfer is well-planned and successful at the site.
- Conduct training for technical staff and inculcate quality and compliance culture.
- Host audits by customers and regulatory authorities.
- Provide regulatory/customer audit response and track CAPAs.
- Investigate quality issues and provide technical clarifications.
- Identify infrastructural requirements and procure necessary resources.
- Derive mechanisms for productivity measurement and achieve QA&QC goals.
- Respond to marketing requests and update closure of quality notifications.
- Prepare and review quality trends of products.
- Respond to regulatory queries related to analytical validation.
- Carry out qualifications and validations as per schedule.
- Prepare Annual Product Review and steer Quality Management reviews.
Requirements:
A candidate with experience in Microbial Fermentation (Classical) from Biotech/Pharmaceutical API industry is preferred.
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