DGM- Production (Site Production Head)

Responsibilities

• Production planning and coordination with senior management.
• Ensure production related activities as per planning and budgeted norms.
• Coordination with other department's documentations and resolve the technical issues of plants.
• Effective utilization of resources (Man, Machine & Material).
• Improvement in yield and quality of products.
• Team building and development of subordinates to take higher responsibilities
• Successful completion of customer and regulatory audits.
• Coordination for up-gradation of GMP and safety systems.
• Coordination with CRD team in commercialization of new product.
• Coordination with projects & QA team for new plan implementation.
• Preparing, reviewing and approving the instructions for the production of intermediates of API'S according to written procedures
• Producing intermediates and API'S according to pre-approved instructions
• Review of validation protocols and investigation reports.
• Evaluate proposed changes in product, process and equipment.
• Coordinate from production end for closer of investigations report and market complaints.
• Review of change control pro forma and planned deviations.
• QMS, OOS, OOT investigation and its subsequent CAPA and its implementation.
• Identify quality / safety related risk in production and its management.
• Participate and co-ordinate the management review meetings.
• Responsible for site activities in absence of Plant Head, inter location transfer of API & Intermediates, ensure teams training timely, APIs & intermediate safety.
• Responsible for HAZOP, HIRA, Process Hazard Analysis.
• Coordinate with RA, CQA, PR, PRA, for routine development and implementation of APIs process in Plant.

Desired Skills

• Experience in production department in a reputed API pharma company (Regulatory).
• Exposure in managing and working with regulatory authorities and norms.
• Experience of USFDA audit is a must.
• In-depth experience and knowledge of production activity.
• Good communication and interpersonal skills.
• Good in MS Office – i.e. Excel, Word, and PowerPoint.
• Ability to work in a fast-paced, demanding, and timeline-driven environment.