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خدمات الدعم التجاري الأخرى
أنشئ تنبيهًا وظيفيًا للوظائف المشابهة

الوصف الوظيفي

Main responsibilities:


Resource and Time Management


  • Allocation of scheduled activity to Operators in the shift as per Production Plan.
  • Allocation of Manpower to associated activity in the shift wherever needed.
  • Allocation of necessary accessories to the operator/manpower as and when needed for completion of the activity.
  • Maintaining discipline amongst the manpower resources at all times and be a role model by strictly abiding the rules and regulation mentioned in certified standing orders.
  • Ensure to complete the scheduled activity (output) within standard time.
  • Prioritize activity in order to provide continuous feed to next process. (Ex. Dispensing to ensure feed for Granulation, Granulation to ensure feed to compression and Compression to ensure feed to coating/packing).

Shift handover and Vital Communication sharing


  • To communicate effectively with shift supervisors and sub-ordinates of the completed activity in the shift.
  • Share Vital Information regarding product critical to manufacturing during shift handovers through Status Board and Direct Communication.

Line Compliance and Adherence to Quality standards


  • Ensure that the activity executed by the Operator/Manpower is adhering to the effective SOP’s and is within the specified parameters/standard in BMR.
  • Identify, troubleshoot, report the Quality defects online if noticed and adhere to stringent AQL checks as specified in Batch Manufacturing Record.
  • Ensure to compile, check and submit the completed batch manufacturing records to Quality assurance.
  • Ensure that the products are manufactured and stored as per the requirements, ensure implementation of the quality system, Good documentation practice for BMR, logbooks and Log cards, ensure that data integrity attributes are followed.

Production planning and scheduling


  • Receive production plan from Manager-Production, plan, execute, interact with cross functional departments for communicating requirement for completion of plan.
  • Monitor daily activity, Ensure that Posting of the completed batches in SAP is carried d out, Plan changeovers in order to maximise activity in scheduled time for Dispensing, Granulation, Mixing and compression/coating.
  • Maintain adequate WIP levels and document for all products manufactured at Goa to achieve scheduled production with optimum resources.

Implement Process Excellence and Projects


  • Improve processes, cycle time, yields, optimum utilization of capacity in order to improve cost of goods manufactured.
  • Devise Action plan in co-ordination with other team members to improve the process, quality and productivity.
  • Update OEE and other equipment details in designated records from time to time and assist the Lean Management in gathering of required accurate data for process excellence.

Training and Development


  • Confirm that you are trained on relevant SOP’s before proceeding for execution of the activity.
  • Train and help subordinate to implement GMP/HSE systems and development of people.
  • Ensure all the new joiners are trained on the job before assigning them the job.
  • Train and help direct reports/sub-ordinates to implement GMP/HSE systems and development of people. Also training & guidance to subordinates for new product transfer strategy & documentation process (Validation protocol, BPR etc.).

Adherence to Site HSE Systems


  • Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
  • Initiate the departmental safety committee meeting.
  • Take suggestion from associates to improve the work conditions with great safety and zero risk.
  • Periodic review of the implemented procedures and evaluation of the same.
  • Train people on safety and their job to ensure zero LTI and IWLT at workplace.
  • Adherence to all health safety & environmental aspects as required by company policies and procedures.
  • Ensure that the implementation of HSE systems, safe working conditions and maintain a culture of continuous improvement.
  • Conducting daily training in the +QDCI meeting address any unsafe condition.
  • Take suggestion from direct reports/sub ordinates to improve the work conditions with great safety and zero risk.
  • Periodic review of the implemented procedures and evaluation of the same.
  • Train people on safety and their job to ensure zero LTI and IWLT at workplace.

Introduction of New Products/Transferred products at Site (Validation)


  • Co-ordinate in new product introduction/transfer (Validation), make schedule batches, make protocol and reports, validate manufacturing activity, and ensure release as per plan to successfully implement products to the Goa site.
  • To Prepare Validation protocol for pilot scale batches, engineering batches and commercial scale batches.
  • Execution and implementation of validation activity as per protocol.
  • Preparation and approval of validation reports. Revision of MFR and BMR for inclusion of Post validation changes.

Quality Compliance activities


  • Ensure completion and implementation of compliance activities in manufacturing i.e., deviation investigation, OOS and OOT investigation, CAPA implementation. Regulatory audit handling and CAPA implementation of the same.
  • SOP revision for routine revision and Inclusion of corrective actions and preventive actions.
  • Change Control management: Logging of change control and ensure to close the same after completion of activity in defined time.
  • Revision of MFR, BMR: Revision for Inclusion/exclusion of material codes, Inclusion of Corrective actions/Preventive actions or any other changes required.
  • Ensure to coordinate with Quality Assurance for implementation of Corrective actions and preventive actions for Quality events.
  • Effectiveness review for shopfloor CAPA’s.
  • Ensure Audit readiness for the Site at all times by following the procedures laid in effective SOP’s.

Qualification & Change Control


  • Assist in Qualification of any new Equipment/Modification: make URS, PQ protocol and reports.
  • Ensure equipment qualification is as per GMP standards and User requirements along with supporting department.

Experience & Qualification


  • Experience: Preferably 2-4 Years
  • Soft skills: MS Word, Excel, SAP, Power point
  • Technical skills: Experience in tablet manufacturing.
  • Education: B.Pharm / M.Pharm

Pursue progress, discover extraordinary

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