Production Manager

Job Description:
  • Experience: 10 to 15 Years
  • CTC: Upto 10 to 15 Lakh
  • Gender: M
  • Openings: 1
  • Department: Production
  • Dosage Form: Injectables - Liquid Injections

Note: Only from Finished Formulation candidate need to apply.

Responsibilities:

Incharge of production and engineering department for  a liquid injection manufacturing plant. Should have a quality mindset and be well versed in cGMP, WHO, FDA, etc. regulations. Willing to work in a challenging and international environment.

Role Description:
  • Candidate must have Liquid Injectable manufacturing and product development working Experience.
  • Ensure timely Dispensing of RM/PPM, Manufacturing & filling planning and Complete BMR & logbook.
  • Plan and execution of monthly Injection activities.
  • Ensure the cleaning of the production area as per sanitization schedule.
  • CIP and SIP of manufacturing and holding tanks and transfer lines.
  • Sterilization of equipment assemblies, storage containers, aseptic area garments, filling area accessories, machine tools any other autoclavable materials used in aseptic area.
  • Proper unloading, storage, and handling of aseptic area articles.
  • To ensure cleaning of pre-filter (return riser, LAF, garment cabinet, pass box) as per schedule.
  • To perform product filter integrity and vent filter integrity as per schedule.
  • To participate in aseptic process simulation.
  • Preparation and filtration of disinfectants
  • Ensure appropriate process validations and calibration of equipment’s.
  • Monitor and ensure right first-time production as per plan while ensuring adherence to production related policies & procedures and Quality & EHS standard.
  • Provide timely feedback to superior on deviations observed during manufacturing and packing activities and suggesting appropriate corrective & preventive actions.
  • Responsible for planning, coordination, and control of manufacturing process to ensure that the products are produced efficiently, and the correct amount is produced at the right cost and level of quality.
  • Ensure the production is on time, meeting quality standards and as per specifications.
  • Maintaining cleanliness and hygiene in sterile area.
  • Team Management – Performance goal setting for team, review team performance. Counselling, training, and developing the Human resource of the department. Ensuring optimum manpower utilization. To prepare training matrix and training reports of production personnel. Maintain team roaster
  • Team Management – Performance goal setting for team, review team performance. Counselling, training, and developing the Human resource of the department. Ensuring optimum manpower utilization. To prepare training matrix and training reports of production personnel. Maintain team roaster
  • Ensure maintenance of documentation as per required guidelines and other quality standards updated by the organization. Ensure cGMP compliance.
  • Ensure capacity utilization of all equipment’s in production areas.
  • Propose & implement product improvement & operational efficiency
  • Manage regulatory and customer audits.
  • Confirm in-process tests as per frequency mentioned in master production and control record.
  • Ensure that products are packed strictly as per MPCR to attain quality products.
  • Procure machine spares, change parts, and other departmental needs.
  • Prepare use requirement specification, Capex, etc. as per requirement.
  • Work with QA/QC department for validation activities, the engineering department for preventive maintenance and with QA for the investigation of market complaints.
Skills Required:
  • Good Communication Skills
  • Good Analytical Skills.
  • Thinking and decision making skill.
  • Experience in facing regulatory inspections.
  • Excellent knowledge of Aseptic processing GMP guidelines.
  • Appropriate oral, written communication and interpersonal skills.
  • Ability to work in a fast-paced, demanding, timeline-driven environment.
  • Innovative and creative mindset.
  • Team Management experience.
  • Good Inter – personal Skills
  • Good Motivation Skills
Apply Now:

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