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  • Posted: Aug 19, 2024
    Deadline: Not specified
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    Cipla Limited is an Indian multinational pharmaceutical and biotechnology company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control and depression; other medical conditions.


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    Operator 4

    Job Purpose

    • Executes production activities by operating machinery and equipment under the supervision of the Production Supervisors, Pharmacists and Pharmacist Assistants. Implements the production plan and targets according to prescribed BMRs, SOPS and cGMP, while maintaining the highest level of Quality, Safety and Productivity. 

    Accountabilities

    Operations and Productivity 1

    • Responsible for timeous line start up 
    • Inspection and certification of clean equipment and the completion of the relevant production documentation in accordance with the relevant SOP’S 
    • Strip down , cleaning, Assemble and Operation of equipment according to production documentation and SOP’s
    • Storage preparations of cleaning and sanitizing solutions according to SOP’s
    • Maintaining stock levels of consumable items thereby ensuring availability for the use in production
    • Ensuring availability of cleaning agents and Cleaning of wall panels, floors, windows equipment as per SOP
    • Conduct start up checklists and regular I.P.C check according to SOP’s and as specified in the production documentation
    • Ensure adjustments settings on machine to ensure quality product produced efficiently
    • All work must be carried out as per condition stipulated in the OHS ACT 
    • Report deviations  immediately to your supervisor/IPC inspector and shift pharmacist
    • Ensure breakdowns are timeously attended to by liaising with the fitter/supervisor and reported to Pharmacist

    Accountabilities 2

    Operations and Productivity 2

    • Participate in production Optimization minimise waste, quick change over, identification and resolve delays/ constraints before they occur, contribute to downtime minimization ensure that all material/documents tools and equipment are available 
    • Is responsible for carrying out line set up process and must ensure accuracy and correctness of all material issued to a job as per BMR/BPR and Syspro document
    • Ensure functional integrity and safety of machine before use and report any abnormality or defect immediately to your Supervisor/Pharmacist
    • Report component that are of in consistent quality and defects immediately to supervisor, IPC inspector and or shift pharmacist
    • Timeous and correct filing in of information on relevant documentation
    • Operation of machine as per good engineering practices
    • Continuous monitoring of quality of products to ensure specification as per Quality Standards are met, and reporting any deviations immediately
    • To be competent in operational, cleaning of equipment as per SOP
    • Complete practical assessment and to be found competent
    • Conduct shift handover between operators.

    Accountabilities 3

    Documentation

    • Timeous and correct filing in information on relevant documentation document e.g BMR/BPR Logbooks etc. SOP’s and protocols or QA approved document log books verification line diaries
    • Assist in the drawing up of relevant documentation e.g  BMR/BPR, SOP’s Protocols, as well as recommendation proposals to existing documentation
    • Able to write operating/cleaning procedures for equipment/processes

    GMP and Safety

    • Maintenance and adherence to cGMP/PICS and safety standards in the department
    • Active participation and liaisons in internal and external quality audits
    • Ensure competency on all relevant SOP’s

    Operational Planning

    • Plan daily activities in order to meet the agreed daily production targets at respective areas
    • Meeting required ORE scores

    Communication

    • Actively participate in regular team meeting and shift handovers

    Education Qualification

    • Matric/ Grade 12 (with Mathematics & English)
    • Added Advantage: National Diploma in Mechanical or Electrical Engineering or equivalent

    Relevant Work Experience

    • 1-3 years relevant experience in a Pharmaceutical Industry

    go to method of application »

    QA Assistant

    Job Purpose

    • QA Assistant is responsible for clerical and administrative duties related to the QA office, including but not limited to capturing of finished product results onto certificate of analysis, scanning of documents to customers, and maintaining the finished goods retention store.
    • Other functions include, printing and issuance of documents, issuance, archiving and destruction of Logbooks and batch documents

    Accountabilities

    • Maintenance of the retention stores by logging of retention samples and pulling out samples for destruction as well as environmental monitoring daily. Preparation of Certificate of Analysis for product release.
    • Scanning of standard documents for third party batch release requirements and e-mailing to respective parties.
    • Electronic filing of release document sets on CMM network.
    • Destroying of expired retention samples/documents as per agreed timelines.
    • Sending all documentation required for batch releases and attend to customer queries.
    • Involvement in investigation of deviations / root causes analysis.
    • Creation and application of release labels for intermediates and finished product where required on site and for all palletized stock prior to dispatch. Requisition and collation of additional release documents as required for by third party applicants such as API COA from QC laboratory
    • Prepares and issues logbooks to users.
    • Retrieves, archives and destroys logbooks as required. Maintains an effective logbook register.
    • Replenish paper and consumables for photocopier General administrative and clerical duties including but not limited to general filling, typing as required, photocopying, faxing, emailing, ordering of consumables.

    Accountabilities 2

    • Assist with preparation of destruction list for documents due for destruction.
    • Shredding of documents that are due for destruction as required
    • Assist with document archiving and destruction in the QA document retention store 
    • Assist with making Authorized, Training and Uncontrolled SOP copies when required
    • Creation and modifying electronic and / or hard copy documents as requested.
    • Maintenance of QA related documentation and records.
    • Checking of Batch documents prior to issuance for correctness.
    • Support QA staff in assigned project work.
    • Ensure compliance with statutory requirements and requirements of Good Manufacturing Practice and cGMP

    Education Qualification

    • Matric 
    • Pharmacist assistant basic/Post basic 
    • Tertiary related qualification will be an added advantage 

    Relevant Work Experience

    • Minimum 2 years' experience in a pharmaceutical environment
    • 2 years clerical/administration experience

    Method of Application

    Use the link(s) below to apply on company website.

     

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