The candidate must have experience in OSD IPQA / DOC. / Validation

Exp.- 0 to 04 (OSD Formulation)

Key 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), Good 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).
• Good analytical, documentation, and problem-solving skills.
• Ability to work effectively in cross-functional teams.
• Willingness to work in shifts (if required).
• Freshers with good academic background and strong interest in Quality Assurance are encouraged to apply.