Assistant Quality Assurance Manager

Company Description

Sceptre Medical India Pvt. Ltd. is a pharmaceutical company specializing in antiseptics and disinfectants. We have over a decade of experience in manufacturing and trading a wide range of products, including hand hygiene and skin antiseptics, surface and environment disinfectants, antiseptic swab sticks, and wet wipes. Our products are known for their excellent performance, high efficiency, biodegradability, glutaraldehyde free, and high impact strength. We have state-of-the-art facilities and a dedicated team that enables us to deliver international standard quality products at the most affordable rates.

Location:

Key Responsibilities:

• Support the implementation and monitoring of Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs) across the facility
• Assist in the development, review, and periodic revision of SOPs in coordination with relevant departments
• Support the implementation and maintenance of the Quality Management System (QMS), including documentation like the Site Master File and Quality Policy
• Participate in review and approval processes for master documents and validation protocols (equipment, process, cleaning, method, and facility)
• Coordinate and monitor validation and qualification activities as per regulatory requirements
• Assist in obtaining and maintaining licenses and certifications such as GMP, ISO, QMS, and other statutory approvals
• Conduct and coordinate training programs on SOPs, cGMP, and quality systems for operational staff
• Prepare and support internal audits; help manage the audit calendar and follow up on CAPAs
• Investigate product quality complaints, identify root causes, and support the implementation of corrective and preventive actions
• Ensure timely and accurate online documentation throughout the production process
• Review and support approval of batch manufacturing records, artworks, and labelling as per statutory requirements
• Assist in vendor qualification processes and maintain audit records
• Ensure proper retention and management of quality records and stability data
• Perform any additional quality-related tasks assigned by QA Manager or Senior Management
• Audit ISO, FDA and INTERTEK, etc is desired.
• Team Management is mandatory. Should have team management experience.

Key Qualifications:

• Bachelor’s or Master’s degree in Pharma, Chemistry, Pharmaceutical Sciences, or a related field
•  8 to 9 years of experience in Quality Assurance, preferably in disinfectants, FMCG, or chemical/pharmaceutical manufacturing
• Strong knowledge of GMP, QMS, ISO (especially ISO 9001 and ISO 13485, if applicable), and regulatory standards for wet wipes & disinfectant products (e.g., BIS, CPCB, EPA, or CDSCO guidelines, etc.)
• Hands-on experience with documentation control, batch record review, SOP development, and QA audits
• Familiarity with validation protocols (process, cleaning, equipment), stability studies, and product release procedures
• Experience with quality investigations, root cause analysis, and CAPA implementation
• Proficiency in MS Office and documentation software; experience with QMS platforms is an advantage
• Good understanding of labelling, packaging, and safety compliance for chemical-based products
• Strong attention to detail, documentation accuracy, and regulatory compliance mindset
• Excellent communication and coordination skills to work across production, QC, R&D, and regulatory teams