Block Head

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.