Manufacturing QMS Specialist
Amneal India
Summary
The Manufacturing QMS (Quality Management System) Specialist will be executing routine documentation work, which includes writing and reviewing deviations, change controls, investigation reports, batch records, SOPs, CAPA, etc. This position requires technical expertise in upstream and downstream processes of biologics (Cytokines, monoclonal antibodies manufacturing).
Job description
Essential Duties & Responsibilities
- Support the manufacturing team with a wide variety of documentation.
- Review executed batch records, logbooks, and other associated documents, both Upstream department and Downstream batch records.
- File change controls, deviations, and CAPAs for the manufacturing department.
- Use investigation tools like 5why or 6M method for all critical/major investigations.
- Attend daily meetings with both upstream and downstream processes to get all the documentation requirements for the day.
- Meet weekly with QA to avoid any delay in the QMS closure.
- Author batch records, SOPs, and associated forms/formats required for the manufacturing process.
- Request/submit all GMP documents to QA.
- Support the manufacturing process (shifts) during critical campaigns.
- Wet lab work will not be more than 10% of your time.
- Perform other functions as required or assigned.
- Comply with all company policies and standards.
Qualifications
Minimum Qualifications: Education: A Minimum BA or BS in Biological Sciences or related technical field is required. Minimum 5 years of experience in Biopharmaceuticals. Knowledge of USP and DSP processes.
Special Skills
- Previous investigation training
- Ability to work with other team members and independently - good interpersonal skills.
- Good communication skills: verbal and written, good computer and organization skills, detail-oriented.
- Basic computer skills, including knowledge of Word, Excel, and spreadsheets
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review.
- Knowledgeable in cleaning verification/validation.
Work Environment & Physical Demands
- Ability to work flexible hours as needed.
- Ability to work under pressure and meet deadlines.
- Wear appropriate PPE to work in cleanrooms and/or laboratories that are adequately lit, ventilated, and temperature controlled.
- Desk/computer work (reading, editing, writing documents) required.
- Potential for chemical odor and dust exists.
- Must be able to move around the facility to reach various equipment.
- Physical lifting and shifting required for pushing and pulling pre-made buffer containers
- Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification
- Must be able to stand for long periods of time.
- Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
Requirements
- Minimum BA or BS in Biological Sciences or related technical field
- Minimum 5 years of experience in Biopharmaceuticals
- Knowledge of USP and DSP processes
- Previous investigation training
- Ability to work with other team members and independently
- Good interpersonal skills
- Good communication skills: verbal and written
- Good computer and organization skills
- Detail-oriented
- Basic computer skills, including knowledge of Word, Excel, and spreadsheets
- Knowledgeable in GMP batch manufacturing and packaging documentation; audit and review
- Knowledgeable in cleaning verification/validation
- Ability to work flexible hours as needed
- Ability to work under pressure and meet deadlines
- Must be able to lift at least 25 lbs.
- Must be able to stand for long periods of time
Benefits
- Health Insurance
- 401(k) Matching
- Short-term Incentive Opportunity
- Performance-based Award
Company overview
Amneal India is the Indian subsidiary of Amneal Pharmaceuticals, Inc., a leading U.S.-based global pharmaceutical company specializing in generic and specialty medicines. Established in India in 2008, Amneal has built a significant presence with over $300 million in capital investments and acquisitions. The company operates eight state-of-the-art, FDA-approved manufacturing and R&D facilities across Ahmedabad, Dahej, Vizag, and Hyderabad, employing more than 5,500 professionals in India. Amneal India focuses on producing high-quality essential medicines, including injectables, tablets, and specialty pharmaceuticals, with a collective capacity to produce approximately 60 million units of injectables and 8.5 billion tablets annually. The company has recently expanded its commercial operations in India, launching innovative specialty medicines in oncology, ophthalmology, diagnostics, and hospital care. Amneal's commitment to India includes plans for additional investments of up to $200 million to build two new manufacturing facilities in Ahmedabad for peptide synthesis and advanced sterile fill-finish manufacturing, further strengthening its position as a key player in the global pharmaceutical supply chain.