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Project Details

Quality Assurance Consultant- Pharma

Leading Management Consultancy Firm

 Mumbai / Navi Mumbai, Delhi / NCR, Kolkata, Chennai, Bangalore, Pune, Hyderabad

Posted on:  23/12/2022

Cinque Terre

Starts on:  30/01/2023

BROAD CATEGORY

Manufacturing/Operations

SUB CATEGORY

Quality assurance, Process Engineering / Process excellence,

INDUSTRY

Pharmaceuticals

Company Details

Leading Management Consultancy Firm

Assignment Details

Our client a top-tier management consulting firm is looking to engage with a Consultant.

Key responsibilities:
Quality and Regulatory:
-Deep expertise in understanding plant quality documents and assess GMP status and adherence to quality compliance practices
-Ability to look at regulatory status and inspection documents and assess degree of risk. Eg OAIs / VAIs / 483
-Batch failure records / batch recalls / customer complaints and the nature of capa undertaken
-Assess capability and competence of the quality personnel
-Provide overview of risks from a quality perspective on the business plan

Capacity- To work at 40% for 3-4 weeks

Skills Required

-Prior experience in regulatory experience in Pharma
- Located in or able to travel in India
-15+ years of experience in a regulated oral solid dosage plant as well as exposure to injectable plant and oncology would be needed.

Assignment Duration

1 month(s)

Capacity Required

15-20 Hrs/Week

No. of Positions

1

Nature of Work

On-Site

Profile Requirements

Experience: 15+ years

Qualification : Graduate

fleXpertise required

operational excellenceAPI ManufacturingContinuous improvement processservice deliveryQuality and Regulatoryquality assurance pharmaceuticalOverall Equipment Effectivenessregulatory Quality Assurance

ESTIMATED BUDGET (Total Budget)

-

 

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