Job Description

Greetings from Kashiv Biosciences!!!!

We are looking for Qualification, Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities.

Roles and Responsibilities

• Responsible for Engineering compliance, Equipment Qualification, Validation and QMS activity.
• Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions.
• Representing as a Subject Matter Export of Engineering department in front of regulatory auditors.
• Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness
• Responsible for technical agreements with vendors who have work at Plant premises.
• Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled
• Responsible for change control/deviation management/CAPA Through Quality management System.
• Facing the Regulatory, Customer, Internal Audits and preparation of compliance.
• SOPs and Protocols Training for the new personnel and refreshment training for existing team members.
• Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works.

Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com

Requirements

Candidate Details

• The candidate should be from Pharma industry only having exposure to Drug Substance(Biosimilars)/ Parenteral/ Injectables.
• The Candidate Must have B.Tech/ B.E degree and should be working in Engineering Team.
• The candidate should have minimum 5 Years of experience in handling technical documents.
• The candidate should be aware of GDP/ GMP Process.
• The candidate should have exposure to equipment qualification, Validation and QMS
• The candidate should have good communication skills.