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  • Posted: Sep 5, 2023
    Deadline: Not specified
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  • MSD is a leading global biopharmaceutical company that has been inventing for life for more than a century. Bringing forward medicines and vaccines for many of the world's most challenging diseases. Through our prescription medicines, vaccines, biologic therapies, and animal health products, we work with customers and operate in more than 140 countrie...
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    Quality Assurance Specialist

    About the Job

    Job Description

    • Contribute to the maintenance of training programs for the COMET system.
    • Provide COMET training to site personnel.
    • Management of SAP site material master
    • Create, update and maintain PCR traces to link change controls with SAP.
    • Create and update Quality info record to allow Supply Chain to order components from the approved suppliers.
    • Update and maintain RCT changes to support finished good sales.
    • Maintain inspection plans to support lab results recording in SAP.
    • Create and maintain certificate profiles for finished goods CoA printing.
    • Maintain material shelf-life changes in SAP for finished goods and components.
    • Site Topic Lead and QA support for Computerized Systems
    • Providing the independent quality review of computerized systems documentation to ensure compliance to company standards and applicable regulations throughout the computerized system lifecycle.
    • Support development and implementation of DI Global Procedures (workshops, document reviews, pilots, deployment and implementation)
    • Responsible for collection and presentation of DI compliance (metrics), obstacles and challenges to site management, including a review of the DI topic at the Site Quality Council Meeting per the QC standard
    • Site Topic Lead for Data Integrity (DI) including
    • Development and oversight of the annual DI work plan / coordinates between site/functional management, site/functional SMEs and DI COE
    • Implementation of a DI GEMBA program within site / functional area
    • Supports site for DI Inspection Readiness / Inspection Responses for DI
    • Active participant in DI Knowledge Management Forum / Community of Practice
    • Distribution of DI information within the site / functional area, and from the site / functional area to the DI COE
    • Perform periodic audit trails / Orphan data
    • Create, revise or review Empower methods in working projects.
    • Participation in Health Authority, global quality, internal, & external audits. 12. Participation in deviation initiation and investigations, Quality Risk Management and Change Control Systems.
    • Act as risk lead or quality representative in product quality risk assessments
    • Initiate and complete change controls

    Behavioral Attributes

    • Able to make unbiased and honest judgements.
    • Able to deal with situations requiring interpretative and evaluative thinking.
    • Limited supervision required in day-to-day activities. Listening, integrating diverse perspectives, adds value to the achievement of team goals.
    • Timely decision making.
    • Must conduct their function and roles independently, with integrity, fairness, and objectivity to protect products and patients.

    General

    • Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC).

    Qualifications And Education Requirements

    • Bachelor's degree or National Diploma. Preferably Information Technology, Engineering, Commerce or equivalent.

    Experience

    • Hands-on experience and understanding of automated systems supporting pharmaceutical manufacturing and/or laboratory operations.
    • At least two to five years of experience in delivering Computerized Systems such as SAP solutions or an application support role.
    • Good understanding of the current pharmaceutical industry and applicable regulations, with emphasis in regulatory expectations (SAHPRA).
    • Must demonstrate working knowledge of the principles, theories and concepts of computerized system compliance.
    • Familiarity or practical experience in the implementation of quality systems in a pharmaceutical, laboratory, or biotechnology manufacturing environment.
    • Experience in supporting regulatory inspections.

    Skills

    • Business engagement skills, with ability to collaborate with both technical and non-technical roles.
    • Excellent oral and written communication skills including persuading others and developing cross functional relationships.
    • Analytical problem-solving skills applied to issue identification and resolution

    go to method of application »

    Oncology Sales and Account Manager

    About the Job

    Summary of Position

    • The Sales and Account Manager will be responsible for managing a diverse and experienced team that is responsible for sales activities supporting the Oncology portfolio.
    • Externally, the SM will need to focus on strategic key accounts that will drive the Oncology Portfolio.

    Primary Responsibilities

    People Management

    • Leads, motivates, develops, and trains the sales team according to their objectives.
    • Guide and manage career progression and development with team
    • In close collaboration with the HR department, ensure effective hiring, orientation, training, development, and retention of key talent.
    • Communicates and measures the objectives and gives honest feedback on performances on a regular base.
    • Manages each team member to achieve the goals rewards and recognizes high-performing team members and manages non-performance appropriately.

    Internal and External Collaboration

    • Lead and manage National Key Accounts on area of responsibility.
    • Develop and manage strategic relationship with key wholesaler customers.
    • The ability to liaise with relevant customers on a professional basis is critical (including Specialists, Academia, Scientific Leaders, Pharmacy, Government and Wholesalers).
    • Ensures continued collaboration and communication with all internal and cross-functional stakeholders is critical (including the BUD, Brand and Customer Managers, Data and Digital Stakeholders and Medical).
    • Builds and maintains business relationships with targeted customers, KOLs and authorities and ensures customer satisfaction, trust and loyalty to the company and its products in order to meet or exceed annual sales objectives.

    Development and Implementation of the Sales Plan

    • Ensures the development and implementation of the yearly Sales Plan and monitors the impact and comes with actions.
    • Manage and co-ordinate the implementation of promotional strategies by the sales force for the Oncology Business Unit.
    • Identifies customer needs, segmentation, drivers / barriers, and develops segmentation strategies.
    • Measures the team’s performance, supports SFE guidance and guarantees an accurate CRM system data update.
    • Analyses and concludes on available customer, market, and competitive data and provides feedback to its team on effectiveness of plan’s implementation.
    • Prepares, administers, monitors, calculates, and evaluates customer loyalty programs of the business units.
    • Contribute to cycle meeting preparations and the agenda in close collaboration with marketing-technical departments.
    • Reports sales activities, market trends, competitor activities and any market intelligence data.
    • Stays updated in terms of professional and scientific information and communicates this to the team to stimulate the sales of products and services of the organization for coaching or customer support purpose.
    • Has deep understanding of dashboard use and sales data interpretation.

    Compliance

    • Facilitate and own HCP engagements that require compliance and business approval on behalf of the sales team.
    • The SM will be required to adhere to all relevant requirements, policies, procedures and legal regulations pertaining to health, safety, environment and quality, as well as finance, human resources, and any other regulations as required by the company and relevant to the level of the role and responsibilities of the functions.

    Other Responsibilities

    • Travel within the country is required, as is weekend and evening work when necessary.
    • Manage and own company defined Small Meetings for the sales force, example CME’s, and Rep Initiated Meetings.

    Education

    • The candidate must have accomplished University education degree in a health or biologic, commercial / Business / Management or equivalent.

    Experience

    • A minimum of at least 10 years in the pharmaceutical industry.
    • At least 5 years line management.

    Method of Application

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

     

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