Job Description

This role ensures GMP and GxP compliance in dispensing, manufacturing, and packaging. Responsibilities include machine and area clearance, product sampling, in-process checks, batch record reviews, and raw material verification. The position also involves approving packaging details, reviewing environmental and calibration records, managing change controls and deviations, and ensuring proper labelling and document archiving.

Essential Functions:

To perform Machine and area clearance during dispensing, manufacturing, and packaging operation.
To perform sampling of blend, finished product, reserve sample, stability sample, hold time samples and other in process samples and tmanage sampling aids.
To carry out in process checks, AQL and ANSI Sampling as per respective documents viz. protocol, BMR, BPR, SOPs and other GxP documents.
Review of Master BMR, SOPs, Batch Record Review and Batch Release, Shop floor management.
To ensure GMP practices at manufacturing shop floor.
To verify raw material dispensing activity.
To approve batch coding details during packaging operation.
Review of executed batch records and release for next processing stage.
Preparation and review of CPV data trend.
To perform impact assessment of breakdown memo.
To initiate change control, unplanned and planned deviation wherever required.
To review area, equipment, and cleaning log and tensure proper labelling.
To review environmental monitoring record, calibration records and executed Batch Manufacturing and packaging Records and respective electronic records.
To perform calibration of IPQA instruments.
To ensure appropriate labelling during manufacturing and packaging. Storage, handling and dispensing of printed packing materials.
To review and approve packaging artworks, proofs, and shade cards.
To archive executed documents like BMR, BPR, Hold time Protocol etc..
To review and approve the Quality Notification (Viz Change control and Deviation) during Batch Manufacturing/packaging.

Additional Responsibilities:
To monitor and record the environmental condition of label control room.
To prepare and revise functional SOPs, wherever required.
Activities other than defined in the Job Responsibility are to be done, as per the requirement of HOD, by following HODS instructions and guidance.

Skills:

In-Process Checks & Monitoring - Advanced
Batch Record Review - Advanced
Compliance and Regulatory Knowledge - Advanced
Internal Audits and Inspections - Advanced
Document and Record Review - Advanced
Line Clearance & Batch Record Review - Advanced
Process Deviation Identification & Handling - Advanced
Audit & Regulatory Inspection Readiness (USFDA, EMA, MHRA, EUGMP,WHO) - Intermediate
Risk Assessment & Change Control - Mastery

Monitors production processes in real-time to ensure compliance with specifications and GMP - Intermediate

Education: B. Pharm M.Sc / M.Pharm

Experience: 7 years or more in 7- 9 years

Expert in IPQA related all the key functions.

About Amneal Pharmaceuticals

Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.

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Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.

Industry

Chemicals & Materials

Company Size

5,001-10,000 employees

Headquarters

Bridgewater, New Jersey

Year Founded

2002

Website

amneal.com

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Assistant Manager / Deputy Manager - IPQA

Job Description

About Amneal Pharmaceuticals