Commercial Quality Senior Specialist

2 weeks ago

Johannesburg, Gauteng, South Africa Johnson & Johnson Full time

"Caring for the worldone person at a time" inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. This culture of caring is the focus of our corporate philosophy, that are anchored in the internationally applicable Credo.

The Commercial Quality Senior Specialist is responsible for performing Quality Assurance activities in the Commercial Quality Department.


The Commercial Quality Senior Specialist is responsible for the GMP / GDP quality of, and meeting the applicable requirements for, the products and services marketed by the LOC/ Cluster (including all named-patient materials NPP / SPR process (what are, product samples).


He/she is also responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP/GDP activities the LOC / Cluster undertakes.

This position is also responsible for the continuous improvement of the GMP / GDP status of the LOC / Cluster.


He/she is responsible for the oversight of quality and compliance status of all third parties and other J&J organizations engaged by the LOC / Cluster for the GMP / GDP activities for the LOC/ Cluster.


Implement, maintain, and monitor the GMP/GDP part of the J&J quality system for commercial organisations in the LOC / Cluster

1.

Responsible for the Release of Finished product:

  • Review and release batch documents and Final Product Release Forms from Third Party Manufacturers procedure
  • Sign off of Finished Product Release Forms from Third Party Distributors as per procedure
  • Coordinating sampling and testing of imported finished products between Third Party Distributors and Third-Party Laboratories
  • Followingup on release and liaise with Supply Chain Manager with regards to out of stocks
  • Correct filling of all release documentation
  • Management of Retention Stock

2. Process all QA Complaints

  • Recording of all QA customer complaints
  • Coordinating the replacement of product and upliftment of complaint samples
  • Ensure input of relevant complaints into global database
  • Processing and assessment of QA customer complaints
  • Identifying all QA customer complaints that require immediate action ie Escalation or Recall as per procedure
  • Reconciling all QA customer complains on weekly basis together with Pharmacovigilance and Medical Information departments
  • Ensure all complaints of products that are manufactured by the thirdparty manufacture are reported to and investigated by the thirdparty manufacturer

3. Control Substance Management

  • Ensure activities are carried out in compliance with the specific requirements applicable to controlled substances.
  • Uptodate knowledge of relevant pharmaceutical legislation and GMP / GDP, including any legislation/guidelines relating to controlled substances
  • Applications for Narcotic Export and Import Licenses for Exportation and importation of stock in South Africa
  • Coordination of Narcotic Export Licenses between Janssen and Distributors/Supply Chain
  • Export and Import Permit Triplicate Return to Department of Health
  • Filling and retrieval of Narcotic Export and Import Permit documentation
  • Compilation of annual returns for HA submission

4. Deviations

  • Initiate Quality Investigations on Trackwise
  • Investigate root cause and evaluate deviations, implement CAPAs and conduct Effectiveness checks if necessary

5. Change Control

  • Initiate Change Controls on Trackwise
  • Ensure implementation activities are documented and completed on time

6. Prepare QSMR report and presentation, detailing key activities and metrics in the QA department as per SOP requirement

7. Annual Product Review

  • Review Product Quality Review reports from manufactures and compile summary reports
  • Correct filing of all Product Quality Reviews/ Annual Product Reviews

8. Audit Management

  • Management and execution of internal audits
  • Management and execution of external and supplier audits

9. QA Project/Activities

  • Carry out Quality Assurance Projects related to External Manufactures and Distributors and/or any Janssen QA activities including involvement in EMEA Quality Projects.
  • Attend monthly meetings to discuss quality issues and contribution to quality projects.

10. Act as a Backup

  • Back up support for all other QA functions for Quality Assurance department
  • QL approver for quality related activities.
  • Review and approval of quality related activities and records as Quality Approver for LOC, 3PL and or Distributors.

11. Compliance Matters

  • Ensuring safety reporting requirements (timely AE/PQC reporting) as set out in company policies and SOPs (Standard Operating Procedures) are met and appropriately mana

  • Senior Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa MTN Full time

    Context (Global influences, environmental / industry demands, organizational mission etc.)MTN is entering a new phase in its lifecycle where operational and commercial excellence has become critical for success. The urgency for change has become more heightened amidst increased competitive intensity across all markets in which MTN operates.The Senior...

  • Commercial Pricing Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Edge Executive Search Full time

    Our client, one of the largest law firms in SA are looking to appoint a Commercial Pricing Specialist who will be responsible for creating and maintaining financial models to support Tenders/RFQs, BIDS, quotations, strategic decision-making, and analysing commercial contracts and deals to maximise profitability.Key Performance AreasFinancial Modelling...

  • Senior Specialist: Quality Assurance

    2 weeks ago

    Johannesburg, Gauteng, South Africa Absa Bank Limited Full time

    Bring your possibility to life Define your career with us With over 100 years of rich history and strongly positioned as a local bank with regional and international expertise, a career with our family offers the opportunity to be part of this exciting growth journey, to reset our future and shape our destiny as a proudly African group.Job SummaryThe Senior...

  • Quality Assurance Controller

    2 weeks ago

    Johannesburg, Gauteng, South Africa Quality Analytics Full time

    Quality Assurance Controller (Pharmaceutical Experience) Home / Jobs / Quality Assurance Controller (Pharmaceutical Experience) Quality Assurance Controller (Pharmaceutical Experience) Quality Assurance Controller (Pharmaceutical Experience) – We are urgently recruiting for a Quality Assurance Controller (must have Pharmaceutical industry experience) to...

  • Commercial Quality Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa BI AH ZA (Proprietary)Ltd Full time

    The Position: AH - Commercial Quality Manager and Responsible Pharmacist, in Johannesburg, South Africa.Posting end date:17th of NovemberTasks and Responsibilities:Managing Commercial Quality Function and Responsible Pharmacist in South Africa for the Boehringer Ingelheim Animal Health South Africa (BIAHZA) legal entity by ensuring the implementation of a...

  • Quality Assurance Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Six Sense Full time

    Gauteng, Johannesburg Annually Cost To Company (Market related)A well-established short term insurer is seeking to appoint a Quality Assurance SpecialistPerforms complex level proactive (risk) reviews, quality assurance follow-ups, continuous monitoringprojects and general quality assurance support to key stakeholders.QUALIFICATIONS & EXPERIENCE: Bachelor's...

  • Quality Assurance Manager

    2 weeks ago

    Johannesburg, Gauteng, South Africa F & G Sourcing Specialist Full time

    F and G Sourcing Specialist is assisting a reputable Security Services client that is seeking a skilled Quality Assurance Manager to join their company that is based in Johannesburg.The QA Manager will be responsible for executing the strategic direction during the development, deployment, maintenance, and monitoring of Quality Assurance; technologies,...

  • Commercial Property Valuations Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa FirstRand Full time

    Job DescriptionHello Future Commercial Property Valuations SpecialistWelcome to FNB, the home of the #changeables. We design for the shapeshifters and deliver products and services that make us incredibly proud of people that make it happen.As part of our team in FNB Commercial Property Finance First Rand Valuations, you will be surrounded by unique talents,...

  • Specialist - Sourcing - Commercial Partnerships

    2 weeks ago

    Johannesburg, Gauteng, South Africa MTN Nigeria Full time

    Sourcing Specialist: Commercial, Partnerships, Devices & Indirect is responsible for day-today sourcing activities in conjunction with cross functional team to source goods and services and recommending to upper level staff members and/or Sourcing Committee on which suppliers / partners to contract with.The Sourcing Specialist Commercial, Partnerships,...

  • Commercial Account Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa TotalEnergies Full time

    PaysAfrique du SudLieuSouth AfricaLieu de travailJOHANNESBURG(ZAF)Société employeurTotalEnergies Marketing South Africa (Pty) LtdDomaineCommerceType de contratCDIExpérienceMinimum 6 ansAs a Commercial Account Specialist you will possess the following:Engineering, Commercial or related qualification is preferred but not essential. Minimum 5 years of...

  • Senior Lawyer Corporate/commercial

    2 weeks ago

    Johannesburg, Gauteng, South Africa Herbert Smith Freehills Full time

    JOHANNESBURGTHE OPPORTUNITYCorporate/CommercialOur corporate practice includes, but is not limited to M&A, capital markets, investment funds, commercial contracts, corporate restructurings and regulatory matters. Our corporate team offers a wide variety of product offerings to both internal clients and directly to high profile external clients across...

  • Senior Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Telebest Full time

    Our client has an opportunity available for a Senior Specialist in the Product Enterprise Security Service departmentRequirements:3+ years tertiary diploma.Relevant certification or accreditation with the professional body as required for this role.Fluent in origin language with basic English skills.2+ years' experience in an area of specialization coupled...

  • Commercial Sales Support Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Philips Full time

    Job Title: Commercial Sales Support Specialist (graduate programme)As a Commercial Sales Support Specialist you will contribute to increasing the consumables sales in South Africa looking at complete sales cycle and supported by the respective sales enablers (demand planning, marketing activities, sales calls shadowing).Start date:01 April 2024Duration:12...

  • Senior Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Telebest Full time

    Our client has an opportunity available for a Senior Specialist in the Product Enterprise Security Service department.Requirements:3+ years tertiary diploma.Relevant certification or accreditation with the professional body as required for this role.Fluent in origin language with basic English skills.2+ years' experience in an area of specialization coupled...

  • Quality Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa CA Global Headhunters Full time

    Reference Number:MHUOur client is a mining services company that are global leaders in manufacturing quality Certified Reference Materials for mining and exploration industries. The Quality Specialist is responsible for managing and coordinating all quality systems, compliance requirements, record keeping and reporting for all proficiency testing schemes....

  • Senior Platform Engineer

    2 weeks ago

    Johannesburg, Gauteng, South Africa Kerridge Commercial Systems Full time

    "At KCS we've introduced a flexible hybrid work policy, where employees spend three days in the office and two days working from home. This approach promotes a balanced work environment that combines office collaboration with the comfort and convenience of remote work." We are looking for a Senior Platform Engineer with a strong Linux and DevOps...

  • Senior Specialist

    2 weeks ago

    Johannesburg, Gauteng, South Africa Tych Business Solutions Full time

    Job ID: 76552Date Posted: Posted 5 hours agoLocation: JohannesburgJob Title: SENIOR SPECIALIST (DATA ANALYST) FTC - JOHANNESBURG - GAUTENGKey Performance Objectives, TasksOperatinal output Perform analysis to uncover potential ARPU uplift opportunities on subscriber cohorts for bespoke targeting and treatment. Work closely with the Customer Engagement team...

  • Senior Specialist Solutions Architect

    2 weeks ago

    Johannesburg, Gauteng, South Africa Gradznet Full time

    Senior Specialist: Solutions ArchitectureKey Deliverables Translate the customer requirements into working solutions Input into business cases to understand costs, risk and benefits of solutions Follow all relevant steerco and approval practices for customer solutions Obtain business approval through set forums on new innovations required for customer...

  • Commercial Quality Officer Temp

    2 weeks ago

    Johannesburg, Gauteng, South Africa Reckitt Full time

    Want to set the standard for success? As a Commercial Quality Officer Temp, you'll have the freedom to make our business fitter than ever.Commercial Quality Officer TempJohannesburg, GautengCompetitive Salary Responsible for our implementation and maintenance of an effective Commercial Quality Management System to ensure that local operations are in...

  • Senior Prepaid Analyst

    2 weeks ago

    Johannesburg, Gauteng, South Africa TalentCru Full time

    Job Title: Senior Specialist Prepaid AnalystCompany: Leading telecommunications companyOur client in the telecommunications industry is looking for a Senior Specialist Prepaid Analyst to join their team on a 6-month Independent Contract basis in Midrand. As a Senior Specialist in Prepaid Analytics, you will collaborate with stakeholders to evaluate product...