Executive QA Formulation

Sarthee Consultancy; Mumbai; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Sarthee Consultancy is seeking a QA/Manufacturing Compliance professional to monitor manufacturing and packaging processes, ensuring line clearance and in-process checks are rigorously followed.

The role requires proficiency with DOC-MS systems, SOP preparation, deviation handling, and change control, along with protocol reviews and coordination between RCD and manufacturing. Knowledge of validated software meeting FDA 21 CFR Part 11 is essential.

Qualifications

• Hands-on experience monitoring manufacturing and packaging processes.
• Experience with line clearance and in-process checks.
• Proficiency with DOC-MS systems and SOP preparation.
• Deviations handling and change control experience.
• Involvement in TT activities including protocol review and coordination between RCD and manufacturing.
• Familiarity with validated software meeting FDA electronic records and signatures requirements.
• Understanding of equipment qualification and process validation.
• Experience with E-BMR/E-Log for real-time documentation and traceability.

Responsibilities

• Monitor manufacturing and packaging processes and ensure line clearance.
• Conduct in-process checks and ensure compliance with SOPs.
• Handle deviations and support change control processes.
• Coordinate protocol reviews and TT activities between RCD and manufacturing.
• Maintain validated software systems for electronic records and signatures.
• Perform equipment qualification and process validation activities.
• Maintain E-BMR/E-Log documentation for traceability.

Skills

Line clearance

In-process checks

Deviation handling

Change control

DOC-MS systems

Protocol review

Risk assessment

Equipment qualification

E-BMR / E-Log

Tools

DOC-MS

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.

uality 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.