Auditor- QA
Jubilant Pharma Limited
Summary
The QA Auditor is responsible for providing QA inspection/auditing of manufacturing operations to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP).
Job description
Job Description
The QA Auditor is responsible for providing QA inspection/auditing of manufacturing operations to ensure that all products produced meet labeling, dating, and packaging requirements as defined by Standard Operating Procedures (SOP's) and current Good Manufacturing Practices (cGMP).
- Process final container samples; perform inspection/sampling according to SOP, Protocol or client request memo.
- Review and approve product records and entries for completeness and accuracy.
- Assure that labeling and packaging lines are clean and free of materials and components from previous lots. Perform visual inspection of product vials and packaging over extended periods of time (8-10 hours/day, with appropriate breaks).
- Assure that through a system of auditing that cGMPs are followed in manufacturing and finished product packaging areas.
- Recognize potential problems and/or document problems encountered. Follow up with department supervisors to assure corrective actions are taken to resolve any deficiencies in product quality or manufacturing systems and procedures.
- Conduct annual retention sample inspections.
- Other tasks as assigned.
Qualifications
Required:
- High school diploma or equivalent required.
- Minimum 1 year related experience (with no degree).
- Electronic documentation management system and/or LMS experience.
- cGMP and pharmaceutical manufacturing knowledge.
- Must be able to recognize deficiencies in product quality and report these to the appropriate supervisor(s).
- Must have a thorough understanding of the QA and manufacturing systems as related to the testing and packaging operation and batch records.
- Working knowledge of Microsoft Office.
Preferred:
- Pharmaceutical experience.
- FDA regulated Industry Experience.
- Visual Inspection Qualification knowledge.
Working Environment
- 14/14 Corrected Near-Point
- Pass Color Deficiency Test
Other Physical Requirements
- Ability to lift 40 pounds unassisted
- Prolonged standing
- Bending and reaching. Ability to stoop to access lower shelves for samples/inspection.
Requirements
- High school diploma or equivalent required
- Minimum 1 year related experience (with no degree)
- Electronic documentation management system and/or LMS experience
- cGMP and pharmaceutical manufacturing knowledge
- Must be able to recognize deficiencies in product quality and report these to the appropriate supervisor(s)
- Must have a thorough understanding of the QA and manufacturing systems as related to the testing and packaging operation and batch records
- Working knowledge of Microsoft Office
- 14/14 Corrected Near-Point
- Pass Color Deficiency Test
- Ability to lift 40 pounds unassisted
- Prolonged standing
- Bending and reaching; ability to stoop to access lower shelves for samples/inspection
Benefits
- Medical Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- Health Savings Account
- Life Insurance
- AD&D Insurance
- Short-Term Disability Insurance
- Long-Term Disability Insurance
- Employee Assistance Program
Company overview
Jubilant Pharma Limited is a global integrated pharmaceutical company headquartered in Singapore with operations spanning multiple continents. As a wholly-owned subsidiary of Jubilant Pharmova Limited, the company operates through three core business segments: Specialty Pharmaceuticals, CDMO (Contract Development and Manufacturing Organization), and Generics & APIs. The Specialty Pharmaceuticals division focuses on radiopharmaceuticals with a network of 48 radiopharmacies in the US, along with allergy immunotherapy products where it holds a 25% market share in the US allergenic extract market. The CDMO segment provides contract manufacturing services for sterile injectables and non-sterile products, while the Generics & APIs business manufactures active pharmaceutical ingredients and solid dosage formulations. With approximately 5,200 employees worldwide, Jubilant Pharma operates six manufacturing facilities serving regulated markets including the US, Europe, and other regions across over 75 countries. The company is recognized as a 'Partner of Choice' by leading pharmaceutical companies globally and maintains strong market positions in radiopharmaceuticals, allergy therapy products, and several key generic formulations.