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DGM- Production

3 months ago

Bhopal, India Unichem Laboratories Limited Full time
ResponsibilitiesProduction 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 responsibilitiesSuccessful 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 proceduresProducing intermediates and API'S according to pre-approved instructionsReview 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 SkillsExperience 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.

QualificationB.Tech/B.E. or MS/M.Sc(Science)

LocationPithampur, Madhya Pradesh