Job Title

Position: Production Block Head (Sterile & OSD) Department: Production Designation: Deputy General Manager Total Years of Experience: 18 to 20 Years Education Qualification: B. Pharma Job Role: Block Management (Block A, Block F and Finished Goods Warehouse), Manufacturing, Packing, QMS and Investigation Reviewer/Approver. Responsibilities: To meet the production schedule. To ensure the implementation of current Good Manufacturing Practices and SOPs at work place. To maintain and improve the product quality as per standard. To ensure accuracy, reliability, validity, integrity and completeness of the cGxP data/records. To plan the department activities as per weekly delivery schedule for OSD and Liquid orals. To ensure the effective control on man, machine and material in the department. To participate and coordinate various on-going qualification and validation activities. To ensure the completeness of all the trainings (SOPs, Technical, Developmental and Regulatory etc.) assigned to block personnels. To organize and implement the on-job training activities in the department. To ensure the implementation of EHS practices during work. To enforce and discipline in the department. To ensure the maintenance of equipment and upkeep of department constantly. To control the rejection during manufacturing and packing operations. To do counseling and grievance handling of the subordinates. To prepare, review and approve the Standard Operating Procedures. To evaluate deviations, change controls and other quality documents for appropriate conclusion. To ensure the market compliant investigations as per the track wise module and its timely closure and awareness training to all the concerned persons. Handling of QMS related activities of Block. To monitor the activities of Block A, Block F and Finished Goods Warehouse. To carry out the batch failure investigation for root cause identification and accordingly appropriate corrective action and preventive action taken. To review and approve the equipment qualification protocols, process validation protocols, reports, specifications and master formulae. To ensure compliance to the learning management procedure. Will be the signing authority in all the specific required documents in absence of the site head. To ensure compliance to the training management procedures. To ensure an adequate number of trained employees are dedicated to perform and supervise the GxP functions and responsibilities they are assigned. To ensure employees have the education, skills, training and experience or a combination thereof, to perform assigned job functions. To appoint Site Training Program Lead. Ensure that this additional responsibility deliverables have been reflected in the employee annual Objectives. To ensure full support of the Site Training Program Lead by all GMP regulated departments at the site. To review effectiveness of the Site Training Program Lead, discuss role execution, responsibilities and concerns. To review site metrics associated with Training Program.