Section Manager - Production (Manufacturing)

Job Description Ensuring the execution of validation activity of Formulation, Filling Material Preparation Areaequipment s dedicated with co-ordination with QA or internal and external agencies as per validation schedule.
Responsible for review of SOP s, validation protocols, extended documentsreports preventive maintenance schedule, log books, calibration schedules and regulatory guidelines.
To ensure the cleaning, operation, documentation maintenance of all dispensing, formulation, filling, solution material preparation area as per production planning.
To evaluate and monitor the training need of the immediate subordinates and arrange for the on job training for the staff.
To ensure GMP compliance as per the applicable National and International rules and guidelines such as Schedule M and WHO.
Coordination with other departments, R D and other manufacturing sites for technology transfer of production process.
Coordination with Warehouse QA QC RA HR Administration Accounts and Maintenance departments for the smoother functioning of manufacturing activities. Planning Execution of medial fill activity as per schedule.
To manage coordinate the supply chain of products being manufactured at site.
To create an organization culture where people believe in building process capability by building functional capability (Functional capability to serve process objective).
Responsible for handling incident deviation, their root cause evaluation effective CAPA compliance w.r.t. minimize the re-occurrence of same type of incident.
Responsible to ensure the online documentation as cGMP along with routine log book management of production activity equipment.
Development of Subject Matter Expert (SME) for better production activity.
To prepare and or review the assessments associated to the software or GXP equipments.
To prepare and or review the DIM associated to the Software or GXP equipments. Competencies Must understand Aseptic Behavior (aseptic handling, aseptic working aseptic cleaning).
Must understand Sterile Operations, Scientific practices process criticalities of Injectable manufacturing.
Analytical approach Good in trend analysis, data evaluation process calculations. Adequate, Timely Quality deliverance Output within stipulated timeframe. Regulatory knowledge guidelines Schedule M, ICH, WHO TRS, ISO.
Thorough understanding of PQS its compliances with risk based approach and patient safety. Experience 9-12 years (Must have exposure of both Sterile Injectable manufacturing)