Preparation of production plan by using proper utilization of equipment capacity, inventory control, manpower utilization and delivery of products in time
Placebo, Scale up and Exhibit batches of pharmaceutical Solid ,Semi Solids and Liquids dosage forms. Ensure compliance of CGMP , ISO and other various quality measures is a plus .And maintain appropriate document requisite documentation/ records.
Manufacturing Record: Preparation and approval of Master formula, Batch manufacturing and batch packaging Record.
Operational SOP and Protocols Preparation .
Training records preparation and maintenance for technicians /operators. Involved in preparation of Standard Operating Procedure (SOP) for newly installed equipment.
Review and approval of qualification documents, process and cleaning validation protocols.
Involved in the area qualification activities
Coordination with engineering for installation and commissioning of new equipment.
Involved in the purchasing of new equipment and maintenance of machine spares and consumables as per the requirement.
Responsible for the operations and production results of their assigned production lines to include: goal achievement, problem solving coordination and achievement of production results.
Ensure the accurate completion of required documentation per prescribed SOP's and cGMP's.
Provide leadership and direction in Safety, Quality, and Productivity.
Evaluate job performance of all production associates, and assist in the mentoring and development of core teams.
Maintain shift performance and documentation of production results.
Maintain a cGMP Audit ready facility at all times.
Ensure accuracy of department production reporting. Verify daily/weekly results and communicate to all associates.
Responsible for continuous improvement processes to include process implementation, and problem solving processes for manufacturing associates and equipment. Having knowledge in technology transfer and validation activities in .
Desired Candidate Profile
Master Degree in Pharmacist / Chemist / Microbiologist / Engineer, Company Industry: Pharmaceutical
Employment Status: Full time,Employment Type: Employee Years of Experience: Min: 10 years.
Report to : The plant Manager
The Candidate must have experience in following Skills :
Solids , Semi-Solids, and Liquids Production experience, Process Improvement, Analyzing Information, Strategic Planning, Verbal Communication, Attention to Details, Thoroughness, Dealing with Complexity.