Website:
unimaxlaboratories.com
Job details:
Department: Quality Systems
Location: Manufacturing Unit
Reporting to: Management
Role Type: Full-time
Company Description
Unimax Laboratories, headquartered in Faridabad, Haryana, is a WHO-GMP compliant pharmaceutical manufacturer specializing in tablets and capsules within general and beta-lactam categories. The company offers versatile packaging solutions, including PVC blister, alu-alu blister, and aluminum strips, ensuring consistent quality and reliability. With over 180+ products holding valid COPPs and exports to more than 30 countries, Unimax has established a robust global presence. The organization is dedicated to compliance, operational efficiency, and delivering trusted, high-quality formulations to both domestic and international markets.
Role Description
A seasoned Pharmaceutical Quality Systems professional with 15–20 years of experience in non-sterile oral dosage formulations (tablets & capsules) and beta-lactam products. Proven expertise in establishing and strengthening Pharmaceutical Quality Systems (PQS) within WHO-GMP approved manufacturing facilities, with exposure to international regulatory requirements across Asia, Africa, Latin America and CIS countries.
An experienced quality leader with a strong track record of driving regulatory compliance, inspection readiness, data integrity, continuous improvement, and building high-performing QA/QC teams.
Responsibilities
- Provide strategic leadership and oversight of the Pharmaceutical Quality System (PQS), ensuring compliance with cGMP and global regulatory requirements.
- Develop, implement, and continuously improve the Quality Management System (QMS) aligned with international regulatory expectations and industry best practices.
- Drive implementation of GMP, GDP, ALCOA+ principles, Data Integrity, CAPA, Change Control, Deviations, OOS/OOT investigations, and Document Management systems.
- Lead regulatory inspections, customer audits, and compliance initiatives, ensuring inspection readiness and timely closure of observations.
- Review and approve key quality system documents, APQR/PQRs, validation and qualification activities, quality investigations, and critical GMP documentation.
- Provide quality oversight for process validation, cleaning validation, equipment and utility qualification, computerized systems, and stability programs.
- Lead internal audits, supplier qualification programs, compliance assessments, and continuous quality improvement initiatives.
- Mentor and develop QA and QC teams while fostering a strong quality culture across the organization.
- Collaborate with Manufacturing, Engineering, Regulatory Affairs, Supply Chain, Procurement, and Warehouse to strengthen compliance and operational excellence.
- Develop quality policies, SOPs, training programs, and compliance strategies aligned with global regulatory expectations.
Core Competencies
- Pharmaceutical Quality Systems (PQS)
- Quality Management Systems (QMS)
- WHO-GMP & International Regulatory Compliance
- Regulatory Inspections & Customer Audits
- Data Integrity (ALCOA+)
- GMP & Good Documentation Practices (GDP)
- CAPA, Deviations, Change Control & OOS/OOT Management
- APQR/PQR
- Process Validation & Qualification
- Supplier Quality Management
- Internal Audits & Inspection Readiness
- Continuous Improvement
- Team Leadership & Cross-Functional Collaboration
Preferred Experience
- 15–20 years of experience in pharmaceutical manufacturing.
- Strong exposure to non-sterile formulations and beta-lactam manufacturing.
- Experience leading Pharmaceutical Quality Systems in WHO-GMP approved facilities.
- Exposure to regulatory inspections and customer audits across international markets.
- Demonstrated ability to build robust quality systems, strengthen compliance, and lead organizational quality improvements.
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