Head of Quality Assurance
1 month ago
Job Summary :
The Quality Assurance (QA) Head will be responsible for overseeing routine site QA activities to support various business objectives, ensuring compliance with the latest regulatory requirements, and leading continual improvement in quality systems. The role involves coordinating with multiple departments, including Quality Control, Manufacturing, Engineering, and Regulatory Affairs, to ensure smooth execution of validations, qualifications, and system implementations. The QA Head will also lead audit compliance initiatives, drive cost/resource optimization, and spearhead automation efforts to enhance compliance and reduce manual activities. This position requires proven experience in leading QA teams in pharmaceutical formulations, particularly in Oral Solid Dosage (OSD) setups, along with expertise in regulatory audits, strong communication, and technical writing skills. Proficiency in tools such as Six Sigma, ISO 9001, or quality metrics is highly desirable.
Job Description :
- Responsible for routine Site Quality Assurance activities supporting various business objectives.
- Continual improvement in Quality Systems through review and updation of various procedures and activities so as to meet compliance goals with productivity.
- Ensure that facility and systems are in compliance with latest Regulatory requirements.
- Lead and Support various functions like CAPA, Validations, Qualifications, IPQA for drafting investigations and reports and provide timely decisions.
- Coordinate with QC, Manufacturing, Packing, Warehouse, Engineering, and other corporate functions like Regulatory, for various activities like Validations, Qualification, Tech transfers, System implementation, etc.
- Responsible for audit compliances, internal audits, MIS on compliance status.
- Lead the site for successful audits. Ensure audit readiness anytime.
- Spearhead cost/resource optimization initiatives with business and compliance perspective.
- Drive initiatives like MES and automation with Plant functions for improved compliance and eliminate man dependent/manual activities.
- Key member of business and compliance team, being responsible for advising and proposing improvement to meet above objectives.
Critical Attributes:
- Proven experience in leading QA teams in pharmaceutical formulations (OSD) setups.
- Strong experience with regulatory audits.
- Excellent communication, logic, and technical writing skills.
- Proficiency in Six Sigma, ISO 9001, or quality metrics is a plus.
Location : Ambernath
Experience : 20-25yrs
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