Sr. Officer / Sr. Executive - QA

FDC

5 - 10 years

3 - 6 Lacs

aurangabad

Posted:20 hours ago| Platform:

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Skills Required

validation parenteral ipqa qms injectables cleaning validation process validation inprocess quality apqr change control bpr review deviation in process quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Roles and Responsibilities

Conduct BPR reviews, Change Control activities, Deviation investigations, Cleaning Validation, In-Process Quality Assurance (IPQA), Parenteral product validation, and Process Validation.
Ensure compliance with Good Manufacturing Practices (GMP) guidelines and maintain accurate records of quality control procedures.
Collaborate with cross-functional teams to resolve issues related to injectable products and parenteral manufacturing processes.
Develop and implement effective QMS systems to ensure adherence to regulatory requirements.
Provide technical support for APQR initiatives within the organization.

Desired Candidate Profile

5-10 years of experience in pharmaceutical industry with expertise in BPR review, change control, cleaning validation, deviation investigation, injectables/inprocess quality assurance/ipqa/parenteral product validation/process validation.
Bachelor's degree in Pharmacy (B.Pharma) or Master's degree in Science (M.Sc.).
Strong understanding of GMP regulations and ability to apply them effectively in daily work.
Exposure of Regulatory Audits

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