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Overview:
Hetero Healthcare Ltd is a leading Innovative Pharmaceutical Company in India, headquartered at Hyderabad. We aim to improve the quality life of the people with our product line and along with a continuous Research and Development process. Our team is more committed, to finding tomorrow’s cures and treatments for some of the most serious diseases. We believe that new medicines are an integral part of the healthcare system, Hetero Healthcare helps patients better by leveraging our industry-wide experience, deep technology expertise, comprehensive portfolio of Products and vertically aligned business model for the upliftment of the human life.
For More Information Visit: https://www.heterohealthcare.com/
Designation: QA Senior Manager
Experience: 18+ Years
Department: Quality Assurance
Location: Guwahati, Assam, India
Qualification: B.Pharm / M.Pharm / MSc or relevant life sciences qualification
Job Summary:
We are looking for an experienced and result-oriented QA Manager / Senior Manager from the pharmaceutical industry to lead and manage Quality Assurance operations at our manufacturing facility in Assam. The candidate will be responsible for ensuring compliance with cGMP, regulatory requirements, quality systems, and overall product quality standards.
The ideal candidate should have strong exposure to pharmaceutical manufacturing environments, regulatory audits, documentation systems, validation processes, and team management.
Key Responsibilities:
- Lead and manage overall Quality Assurance activities for the manufacturing plant.
- Ensure compliance with cGMP, GDP, GLP, SOPs, and regulatory guidelines.
- Handle and monitor QA systems including:
- Change Control
- Deviations
- CAPA
- Market Complaints
- Risk Assessment
- Annual Product Quality Review (APQR)
- Review and approve:
- Batch Manufacturing Records (BMR)
- Batch Packing Records (BPR)
- SOPs
- Specifications
- Validation protocols and reports
- Coordinate and manage internal, customer, and regulatory audits.
- Ensure audit readiness for regulatory authorities such as WHO, USFDA, MHRA, and other international agencies.
- Oversee qualification and validation activities including:
- Equipment Qualification
- Process Validation
- Cleaning Validation
- CSV (if applicable)
- Drive continuous improvement initiatives for quality systems and compliance culture.
- Monitor investigation of deviations, OOS/OOT, and implementation of effective CAPA.
- Collaborate with Production, QC, Warehouse, Engineering, and Regulatory teams to ensure smooth operations.
- Lead, mentor, and develop the QA team for effective performance and compliance.
- Ensure data integrity and adherence to quality standards across operations.
Required Skills & Competencies:
- Strong knowledge of cGMP and pharmaceutical regulatory requirements
- Experience in handling regulatory audits and inspections
- Excellent documentation and investigation skills
- Strong leadership and people management abilities
- Exposure to sterile / OSD / injectables / API manufacturing (mention as applicable)
- Knowledge of data integrity and quality risk management
- Good communication and interpersonal skills
- Ability to work in a fast-paced manufacturing environment
