Officer / Executive - QA (P)

Quality HR Services

1 - 3 years

2 - 3 Lacs

vapi

Posted:4 days ago| Platform:

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Skills Required

quality control ipqa oos quality assurance qms standard operating procedures pq fda bmr documentation packaging gmp internal audit change control quality systems quality management computer skills sop product quality manufacturing process

Work Mode

Work from Office

Job Type

Full Time

Job Description

Responsibilities:

Review and approve batch records, laboratory data, and other relevant documents related to the manufacturing process.
Ensure all operations comply with GMP guidelines, FDA documentation requirements, and internal quality standards.
Conduct internal audits to assess adherence to GMP, standard operating procedures (SOPs), and other regulatory requirements.
Participate in the review and approval of finished product batch records and assist in product release processes.
Investigate and manage deviations, CAPAs (Corrective and Preventive Actions), and OOS (Out of Specification) results in a timely manner.
Support the Quality Control Laboratory to ensure all testing is performed as per regulatory guidelines and company procedures.
Prepare, review, and approve validation & calibration documentation such as protocols, reports, and qualification documents (IQ/OQ/PQ) for equipment, systems, and processes.
Assist in the execution of validation activities for equipment, systems, utilities, and processes to ensure compliance with GMP and other regulatory requirements.
Apply knowledge of QMS (Quality Management System) software for documentation control, deviation handling, CAPA management, change control, and audit management.
Perform In-Process Quality Assurance (IPQA) checks during manufacturing and packaging to ensure product quality at every stage.
Ensure continuous compliance through training, monitoring, and implementation of best practices in quality systems.

Required Skills

Must be excellent in written and spoken English; net savvy and adept at computer skills.
Logical thinking.
Organizing.
Good in communication.

Required Qualification: - B.Pharm/M.Pharm.

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