Responsible for all activities related to Stability, Validation samples, PM & QC at Dholka plant. • To ensure current valuable laboratory compliances and ensuring all SOPs related to quality control laboratory are prepared and reviewed / implemented properly. • To manage an accurate, reliable, efficient and timely testing function of stability samples. • To ensure that the persons are working in the laboratory with proper compliance and follow the GMP & ALCOA+ Principle norms. • To ensure timely withdrawal of stability sample and plan accordingly. • To ensure timely release of Stability, Validation sample, Packing Material & Penicillin Lab in order to avoid delay in delivery of goods. • To ensure timely regulatory & audit compliance related to Stability sample along with effectiveness. • To ensure that only trained & Qualified and authorized personnel are in working on respective working area. To carry out review and suggest periodic training, wherever required. • To investigate and file change control, deviation, out of Specification (OOS), out of trend (OOT)



report and Laboratory events whenever observed. • To ensure timely closer of QMS related to Stability, Validation sample, Packing Material & Penicillin Lab along with root cause and CAPA. • To review the Specification/STP and to update them from time to time if required. • To communicate the regulatory, technical and quality information to all the concerned. • To ensure the Instrument Breakdown/Qualification/Calibration/Preventive maintenance timely rectification of instrument problems. • To ensure the training about the changes in the standard operating procedure (SOP) if required. • To ensure accurate document preparation / review procedures being carried out relating to stability samples as per the regulatory norms, checking / monitoring them and issue of certificate of analysis to various departments. • To initiate, review and implement the change control wherever necessary after getting it approved from HOD.

📌 Assistant General Manager (Dholka)
🏢 Cadila Pharmaceuticals
📍 Dholka