
Senior Quality Assurance Officer
3 weeks ago
Purpose of the Role:
The Senior Quality Officer will be responsible for ensuring adherence to quality standards across all contract manufacturing units. The role involves conducting audits, implementing quality systems, and collaborating closely with R&D and Corporate Quality Assurance (CQA) teams for New Product Development (NPD) and ongoing quality improvement. The incumbent will act as a key interface between contract manufacturers, R&D, and CQA teams to ensure product quality, compliance, and smooth commercialization of new products.
Qualification & Experience:
- Bachelors/masters degree in chemical engineering, Chemistry, Pharmacy, or related discipline
- Quality certifications like FSSC 22000, ISO 9001, or HACCP will be preferred.
- Required Education Qualification: B.Tech. / B.Pharma
- Required prior Work Experience: 3-5 years.
Knowledge, Skills & Competencies:
- Strong knowledge of Quality Management Systems (QMS) and regulatory compliance (GMP, ISO standards, etc.)
- Hands-on experience in internal and external quality audits.
- Understanding of NPD processes and commercialization requirements.
- Excellent communication, negotiation, and collaboration skills to work with cross-functional teams.
- Analytical mindset with problem-solving skills for quality issues.
- Ability to handle multiple contract manufacturing locations and travel as required.
- Proficiency in MS Office and quality documentation tools.
Job Responsibilities:
- Ensure adherence to quality standards and specifications across all contract manufacturing units.
- Plan, conduct, and follow up on internal/external quality audits and drive CAPA (Corrective and Preventive Actions) closure.
Collaborate closely with R&D and CQA teams for NPD projects, ensuring all quality and regulatory requirements are met.
Review and approve quality documentation, product specifications, and manufacturing records.
- Support vendor qualification processes and continuous improvement initiatives at contract manufacturing sites.
- Monitor product quality performance metrics and implement corrective actions where required.
- Facilitate knowledge sharing and training for contract manufacturing partners on quality systems and compliance.
- Act as a single point of contact between contract manufacturers and internal quality/R&D teams for quality-related concerns.
Reporting Relationships:
Upwards Manager 3P Manufacturing.
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