About
The IPQA performs line inspection as part of the cGMP, SOPs, and policy compliance requirements as per CFR part 111. Performs In-process quality testing in manufacturing and/or packaging areas according to prescribed timelines and accurately captures test results in batch records. The Inspector performs calibrations & measurements on raw materials, bulk products, finished products and packaging components as required in batch records and SOP's. This position reports to the QA Manager and is a key member of the Quality Assurance group. The IPQA Associate is a highly organized self-starter who can work independently, demonstrates a positive attitude, and a bias for action. Areas of Responsibility
IPQA
Level 1:
To support In-process quality assurance activities by performing routine checks and verifications during manufacturing and/or packaging of nutraceutical products. This role ensures that all processes comply with applicable GMP, SOPs, and regulatory requirements. Key Responsibilities: Perform line clearance before starting blending, granulation, compression, encapsulation, coating processes. Perform In-process checks: Blend uniformity sampling, tablet/capsule weight variation, hardness, friability, and disintegration tests etc as applicable. Verify equipment cleaning and area hygiene as per SOP. Collect and label In-process and stability samples under supervision. Packaging Support: Ensure line clearance before packaging activities. Perform In-process checks: Batch number and expiry date printing, label application and carton sealing, primary and secondary packaging integrity etc as applicable. Assist in reconciliation of packaging materials (e.g., printed cartons, leaflets, labels). Documentation: Record observations in IPQA checklists, logbooks, and batch records. Maintain GMP documentation in real-time (legible and error-free). Escalate any deviation or abnormality immediately to the QA Executive/Supervisor. Compliance & Safety: Adhere to company GMP, SOP, and Hygiene policies. Use PPE appropriately. Support during internal/external audits by providing necessary records. Cleans up work following the completion of a shift. Meets all safety expectations and follows all safety practices. Works extended hours and occasional weekend overtime. Other duties as assigned Other Responsibilities Including Safety: Requirements
Education & Qualification: IPQA
Level 1:
01 year (Freshers with training or internship in QA preferred) Or equivalent combination of education and experience. High School diploma is required; BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA
Level 2:
Minimum of 3+ years of experience in a QA Inspector within a nutritional's supplements, food, consumer products or pharmaceutical company. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. IPQA
Level 3:
35 years in IPQA or related QA roles in nutraceuticals, pharmaceuticals, or food manufacturing. Or equivalent combination of education and experience. BS degree in a life science discipline (e.g., Chemistry, Microbiology, Biochemistry) a plus. Certifications, Licenses, Credentials:
N/A Skills & Ability: IPQA
Level 1:
Basic understanding of GMP, nutraceutical processes, and QA principles. Good observation and attention to detail. Willingness to work in production areas (shifts, growing zones). Ability to follow instructions and standard procedures accurately. Basic proficiency in English and documentation practices. IPQA
Level 2:
Strong knowledge of IPQA functions, SOPs, and process flow in nutraceuticals. Understanding of basic analytical parameters (weight variation, friability, etc.). Good documentation and observational skills. Proficient in using basic lab and QA tools (weighing balances, disintegration testers). Familiar with regulatory guidelines (FSSAI, WHO-GMP, USFDA, HACCP). IPQA
Level 3:
In-depth understanding of nutraceutical manufacturing processes and regulatory compliance. Proficient in QA documentation, process audits, and deviation handling. Strong analytical and decision-making skills. Familiar with QMS tools, GMP documentation, and data integrity principles. Working knowledge of SOP writing, change control, and risk assessment. Physical Requirements (lifting, etc.):
Ability to lift up to 35 lbs.; occasionally lift and move up to 50 pounds. Must stand and walk on production floor a minimum of 6 hours per shift Uses hands to finger, handle, feel, or operate objects or controls, lifting to waist height and/or above shoulder height, frequent bending from waist, or squatting, walking short distances. Occasionally works from a rolling ladder or step stool. Must be able to wear all PPE including lab coat, face mask, booties, gloves, safety glasses. Work Environment (Office, Warehouse, temperature extremes, etc.):
Work is regularly performed inside a manufacturing and packaging environment where temperatures can be moderate, exposure to dust, odors, noise, and fumes. The noise level is usually moderate. Employees can be exposed daily to chemicals and cleaning agents.
Languages
- English
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