Production Technician - Mumbai Central, Mumbai, Maharashtra, India - DITRC

DITRC
DITRC
Verified Company
Mumbai Central, Mumbai, Maharashtra, India

3 weeks ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter
Description
Required for Saudi Arabia


Responsible for daily production including recovery, equipment/material preparation, formulation, aseptic filling, inspection, and secondary packaging according to Standard Operating Procedures (SOP) and manufacturing batch records (MBR) under supervision.


Job Requirements

Education
Diploma / Vocational Training


Experience
(0-3) years of relevant experience


Language
Good written, read and spoken Arabic. Proficiency in English is a plus.


Professional Knowledge

  • Knowledge of systems such as ICH, GMP, GLP, WHO, GDP
  • Ministry of Health Regulations
  • International and EU Regulations
  • Experience with production equipment/processing such as filler machines, freezer dryers, autoclave, packaging equipment.
  • ISO 8 thru 5 Gowning

Main Competencies
:
able to deliver a high-quality output with work standards.
:
effective communication and working across departments. Great teamwork.
:

adaptable to change, ready to take the initiative, and execute tasks with some supervision and seek direction when in doubt.


Duties and Responsibilities (But not limited to)

Executive & Technical Duties

  • Responsible for setting up, operating, and monitoring processing equipment per Standard Operating Procedures (SOP) and current Good Manufacturing Practices (cGMP) in the areas of preparation, formulation, aseptic filling, lyophilization, product inspection, and secondary packaging.
  • Troubleshooting minor production equipment issues in areas assigned and collaborating with maintenance team as necessary.
  • Gown for Grades C/D and Grade A/B (aseptic) per SOP
  • Recovery (cleaning/line clearance) of work areas in Grade A/B per SOP.
  • Responsible for cleanroom housekeeping and cleaning/disinfection of equipment and cleanrooms including performance of line clearance.
  • Use proper aseptic technique while performing tasks in the Grade A/B areas in accordance with SOPs and regulatory guidelines.
  • Perform product inspection per SOP.
  • Accurate weighing, dispensing, and checking specific chemical compounds/raw materials for formulation per Bill of Materials (BOM) and MBR to ensure batches manufactured contain proper ingredients and quantities.
  • Execution and timely documenting all production activities per SOP and manufacturing batch record (MBR), following cGMP and Good Documentation Practices (GDP). Includes timely closed out of all executed MBRs.
  • Perform all job responsibilities in compliance with applicable EHS/GMP regulations, guidelines, policies, MS Pharma SOP and Safety procedures.
  • Support process deviation investigations as required.
  • Communicating with peers, supervisors, and interdepartmental groups to provide for an efficient drug production process.
  • Actively participate in the creation and revision of MBRs, SOPs, and other GMP documents.
  • Support equipment and facility validation and qualification activities as required.
  • Perform setup (On/Off switching) and ensure the proper running of all production equipment including filling equipment, freeze dryers, autoclave, parts washer, packaging equipment.
  • Maintain Training and Qualification of tasks and duties assigned.

Pay:
From ₹26,300,000.00 per month
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