01Key Responsibilities
In-Process Quality Assurance (IPQA):
Perform line clearance, in-process checks, and monitoring during manufacturing and packaging.
Ensure adherence to Standard Operating Procedures (SOPs), Valuable Documentation Practices (GDP), and cGMP guidelines.
Monitor critical process parameters during production to ensure consistent product quality.
Handle deviation, change control, incident reports, and CAPA documentation.
Documentation (DOC.):
Preparation, review, and control of SOPs, protocols, batch records, logbooks, and other quality-related documents.
Ensure compliance with regulatory and internal documentation requirements.
Maintain controlled copies and support document issuance and retrieval.
Validation:
Assist in preparation and execution of validation protocols (process validation, cleaning validation, equipment qualification, etc.).
Support validation documentation, reports, and related activities.
Coordinate with cross-functional teams for validation and requalification programs.
Desired Skills & Competencies:
Strong knowledge of cGMP, GDP, and regulatory requirements (USFDA, MHRA, WHO).
Positive analytical, documentation, and problem-solving skills.
Ability to work effectively in cross-functional teams.
Willingness to work in shifts (if required).
Freshers with positive academic background and strong interest in Quality Assurance are encouraged to apply. .
