Assistant Manager Quality Assurance OSD

Sarthee Consultancy; Mumbai; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Sarthee Consultancy is seeking a Quality Assurance professional with hands-on experience in monitoring manufacturing and packaging processes, keen on document control and compliance. You will contribute to deviation handling, change control, protocol reviews, and real-time documentation across electronic records and logbooks.

The role requires familiarity with validated software meeting FDA 21 CFR Part 11, and a strong grasp of equipment qualification, process and cleaning validation, and risk

Qualifications

• Hands-on experience in monitoring manufacturing and packaging processes.
• Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control.
• Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing.
• Familiarity with validated software systems that meet FDA electronic records and signatures requirements.
• Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation.
• E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability.
• Quality Management Systems (MS): Implementation and maintenance of MS aligned with regulatory standards.
• Risk Assessment: Ability to conduct and document risk assessments for processes, equipment, and product quality.

Skills

Line clearance

In-process checks

Process monitoring

Deviation handling

Change control

DOC-MS systems

SOP preparation

Protocol review

Coordination with RCD & manufacturing

Regulatory compliance

Tools

Document management systems (DOC-MS)

FDA 21 CFR Part 11 compliance

Job description

Hands-on experience in monitoring manufacturing and packaging processes, line clearance, and in-process checks.

Proficiency in DOC-MS systems, SOP preparation, deviation handling, and change control.

Involvement in TT activities including protocol review, execution, and coordination between RCD and manufacturing.

Familiarity with validated software systems that meet FDA electronic records and signatures requirements.

Strong understanding of equipment qualification (D, I, O, P), process validation, and cleaning validation.

E-BMR G E-Log: Experience with electronic Batch Manufacturing Records and Logbooks for real-time documentation and traceability.

Quality Management Systems (MS): Implementation and maintenance of MS aligned with regulatory standards.

Risk Assessment: Ability to conduct and document risk assessments for processes, equipment, and product quality.