Group Leader / Team Lead

Role & responsibilities

• Collaborate on formulating and analyzing research strategies tailored to market and customer demands.
• Oversee commercial activities, securing approvals from manufacturers and our supply team.
• Assist in selecting manufacturers based on available equipment and machinery for specific products.
• Finalize quality and quantity formulas and product specifications, submitting them to manufacturers.
• Coordinate the preparation and arrangement of registration samples and artwork.
• Liaise with manufacturers to ensure commercial production aligns with our quality and quantity standards and product specifications.
• Collect and review documents from manufacturers.
• Coordinate with external laboratories for sample and product analysis according to our standards.
• Finalize active pharmaceutical ingredient (API) selection based on approved specifications submitted to relevant health authorities.
• Review and submit Product Information Files (PIFs) to manufacturers.
• Submit final quality and quantity standards and product specifications for new product launches.
• Coordinate with external F&D support teams.
• Review analytical data received and support regulatory affairs (RA) team with query responses.
• Arrange API and working substance samples, as well as analytical data like HPLC and certificates of analysis (COAs) for the F&D team.
• Review all documents from external sources and provide them to the RA team.
• Assist the supply team in sourcing API and primary material specifications.
• Review manufacturers' and Opes Healthcare's certificates of analysis for finished products.
• Provide troubleshooting support during new and existing product launches.
• Plan and execute plant visits during commercial production activities.
• Update management on critical changes, incidents, and market complaints.
• Review and approve all GMP documents including SOPs, change controls, deviations, batch manufacturing and packing records, process study protocols/reports, qualification documents, specifications, and standard testing procedures (STPs).
• Approve apex documents such as the Quality Manual, Validation Master Plan (VMP), and Site Master File (SMF).
• Design, review, and approve the Quality Management System (QMS) and associated documents.
• Drive initiatives for continuous improvement and operational excellence.
• Collaborate with other departments to ensure effective implementation of the designed quality management system.

Manage activities related to registration batch manufacturing.

Preferred candidate profile

pharma

THANKS YOU

REGARDS

MILAP RATHOD (7486829377)

HR DEPARTMENT

OPES HEALTHCARE PRIVATE LIMITED