Process development / MSAT / Tech transfer - Onsite

Role & responsibilities

Roles & Responsibilities

• Responsible for Validation which shall include: Preparation/Review/Approve of MPR. Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report.
• Responsible for Tech transfer which shall include: Coordination with Vendor/cross functional teams for Tech transfer activities. Execution of Tech transfer products at Receiving Units.
• Responsible for QIP which shall include: Identifying root cause for QIP. Execution of QIP. Conclusion/Recommendation of QIP.
• Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT.
• Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements.
• Follow up & coordinate with cross functional team for execution of validation.
• Give the input for the monthly reporting system, participate in the internal& external audits, present the documents to auditors/inspection team.

Preferred candidate profile

Perks and benefits