Manufacturing - Downstream - DSP - Executive/ Sr. Exe

Role & responsibilities

• Maintains and documents proper records / log book / BPCRs / Reports as per GDP
• Handling of Chromatography, sterilization & Filtration techniques.
• Coordination with other department VIZ. engineering, QA, QC and R&D for smoothly execution of Technical Documents.
• Coordination with QA for timely issuance, completion, filling of BPCR and other GMP documents.
• Preparation of Performance Verification and PQ and commissioning protocol Understanding & execution of work in line with cGMP.
• Preparation of SOP, BPCR and other Technical Documents.
• Handling of QMS Documents, Handling of DMS.
• Execution of Training related activities of DSP area.
• To ensure the timely dispensing of raw material and Handling of SAP.
• To support in qualification activities of DSP area.
• Execution of Process validation batches. Filling of all records,
• Change Controls and QMS related Documents associated with DSP area.
• Execution of IQ, OQ, PQ of equipments of downstream area.
• Ensuring complete in-process quality control and continuous improvement in process capabilities. Investigating the OOS.OOT and handling process validation& cleaning validation. Plan and actively oversee team and shift activities to meet the production requirements

Location: Plasma Fractionation Centre