Industry: Pharmaceutical (API)
Functional Area: Quality Assurance
Grade / Designation: Manager (M1 / M2)
Role: Quality Assurance Manager
Team Size: 15
Experience required: 12 Years to 16 Years
*This position is based at Visakhapatnam location, Andhra Pradesh.
Required Candidate profile
Responsible for impart training sessions like Periodic, General, GMP as per schedule/ applicable
Responsible for Product Release activities & ensuring its documentation as per the regulatory standards.
Responsible for Handling of OOS and OOT.
Responsible for Preparation / review of Validation Master Plan (VMP) Manual & Schedule.
Responsible for Preparation / review of Site Master File (SMF) & Quality Management System (QMS).
Responsible for Review of Master BPR & Process Flow Chart.
Responsible for Review of Technology Transfer Documents.
Responsible for Handling of QAMS Activities I.e Change Control, Deviation and CAPA etc..
Responsible for Reviewing of Specification & Method of analysis.
Coordinate to conduct and preparation of Quality Review Meeting (QRM), Management Meeting (MRM)
Handling of Internal audits compliance.
To ensure that completed batch production and laboratory control records are reviewed & approved before release of the API for distribution / release
To Handle market complaints, return goods
Handling of vendor management activities
To verify the calibration status of all instruments of Quality Control, Production, Utility, Warehouse and engineering
Lead QA team during the customer/regulatory audits and its compliance.
To support & coordination during the preparation, review & approval of the DMF filings of RA function, as per the current regulatory guidelines.
To monitor the cGMP Compliance in all functions.
Ensure the sample submission to customer as per the requirement, to handle Quality Risk Management, Other functional requirements and Laboratory systems & Compliance.
*Preferred Candidates who has done DMF, CEP filings and Audit preparation of EQDM, USFDA, TGA, JPA etc. regulatory bodies, strong knowledge on QA from API background, Ensuring the complete quality management system i.e Change control, Deviations, Incidents, Out of specifications, CAPA and system effective implementation, Strong communication (written & verbal) skills and leadership skills
Salary: INR 9,00,000 - 14,00,000 PA.
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Role:Quality Assurance/Quality Control Manager
Desired Candidate Profile
PG:MS/M.Sc(Science) - Chemistry, Any Specialization, Any Postgraduate - Any Specialization
Doctorate:Doctorate Not Required
Recruiter Name:Ridhi Prasad
Contact Company:LUPIN LIMITED