Manager – Quality Assurance (OSD) at Acme Formulation, Nalagarh, Himachal Pradesh
Acme Formulation quality assurance hiring is open for a Manager – Quality Assurance (OSD) in Nalagarh, Himachal Pradesh, India. The role is on-site and full-time, with a salary of 1.5M INR/yr – 1.8M INR/yr.
Job Details
Company: Acme Formulation
Position: Manager – Quality Assurance (OSD)
Location: Nalagarh, Himachal Pradesh, India
Work Mode: On-site
Employment Type: Full-time
Salary
1.5M INR/yr – 1.8M INR/yr
Quality Assurance Manager Key Responsibilities
- Lead and manage the overall Quality Management System (QMS), ensuring effective implementation, monitoring, and continual improvement in compliance with cGMP and regulatory requirements.
- Lead and oversee IPQA activities across OSD manufacturing, granulation, compression, coating, capsule filling, and packing operations to ensure process compliance and product quality.
- Lead and manage qualification and validation activities, including equipment, utilities, process validation, cleaning validation, and computer system validation, wherever applicable.
- Review and approve site master documents, including SMF, VMP, SOPs, BMR/BPR, specifications, analytical procedures, artwork, and validation/qualification protocols and reports.
- Review and approve deviations, change controls, OOS, OOT, market complaints, product recalls, and CAPA through eQMS.
- Ensure effective batch documentation review and approval/rejection of raw materials, packaging materials, intermediates, bulk, and finished products, as applicable.
- Ensure appropriate authorization for finished product release and compliance with regulatory and quality requirements.
- Drive implementation of Quality Risk Management (QRM), data integrity, and continuous improvement initiatives.
- Ensure effective investigation, root cause analysis, CAPA implementation, and effectiveness verification for quality-related incidents.
- Lead internal audits, external audits, customer audits, and regulatory inspections, ensuring continuous inspection readiness.
- Review, approve, and monitor contract manufacturers, suppliers, external laboratories, and associated Quality/Technical Agreements.
- Ensure timely execution and monitoring of product stability studies and technology transfer activities.
- Ensure compliance with applicable regulatory updates, pharmacopoeial requirements, and revised GMP guidelines.
- Coordinate with Manufacturing, QC, Engineering, Warehouse, and other functions to strengthen site-wide quality compliance across Acme Formulation quality assurance operations.
- Conduct periodic Quality Review Meetings and monitor QMS performance and timely closure of quality activities.
- Ensure effective implementation of departmental training and competency development programs.
- Manage departmental manpower, budget, KRAs, performance assessment, and resource allocation.
- Drive the organization’s Quality Policy and promote a strong quality culture across the manufacturing facility.
Acme Formulation QA Eligibility Criteria
Educational Qualification & Experience
- B.Pharm / M.Pharm / M.Sc. in a relevant pharmaceutical discipline.
- Relevant experience in Quality Assurance within pharmaceutical OSD manufacturing.
- Strong exposure to USFDA-regulated facilities, cGMP, QMS, IPQA, qualification, validation, audits, and regulatory compliance.
How to Apply
Application Method: Easy Apply
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
CLICK HERE FOR THE ORIGINAL NOTIFICATION / APPLY ONLINE
Apply for this Acme Formulation quality assurance manager job through the original LinkedIn listing using Easy Apply.