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    job details

     

    Position – Site Quality Head                                                                     Local Designation: Associate Director

     

    Technical

    • Ensure maintenance of the licence to continue operation (including implementation of Global Quality Standards in the Site e.g. cGxP and management of Audit and Self Inspection; monitoring of KPIs relating to quality and taking corrective actions; leading Quality Review Board)
    • Ensure timely and quality delivery of product to market (release of batches) according to Regulatory Files and HA Requirements and Customer Expectations; Managing effectively product recalls and customer complaints as required
    • Ensure management of site quality control activities (acceptance, quarantining or rejection of incoming raw materials and components, in-process tests and inspections).
    • Ensure management of analytical development (method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting)
    • Lead the QA organization to meet its objectives and deliverables (performance, development, organizational design, capability building, budget etc) as well as developing a Quality culture and mind-set across the Site.
    • Accountable to ensure that the Implemented QMS is completely aligned with the Corporate Policies/ SOPs, in compliant with all Rules, applicable laws and conditions mentioned in the Licenses (viz. Manufacturing license, Test license, GMP license, etc.) and fully meeting the expectations of Health Authorities (and applicable schedules, guidelines) relevant to the dossiers.
    • Focal point of contact for all Health Authorities and Lead all Health Authority Inspections.
    • Lead a cross functional team to identify Risks (in proactive manner) associated with QMS and mitigate the risks/ reduce the risk to acceptable level.
    • Conceive and drive Quality improvement plans in structured manner.
    • Partner with SCM to develop new Supplier, create Key Supplier Management program for existing supplier.
    • Create a strong oversight on all QMS related matters within the site.
    • Lead Analytical tech transfer and ensure a robust process and analytical method is transferred at site.
    • Guide cross functional team for an effective Investigation, root cause analyses and define appropriate CAPA.
    • Support / deliver / perform all relevant review and approvals of layouts, various documents related to new Product introduction in new facility.
    • Accountable for driving the QC instrument selection, installation and qualification.

     

    Managerial

    • Should have in-depth knowledge on defining &/or aligning Objectives (with N+1), with clear measurables.
    • Should be able to translate all Objectives (“What”) into actionable plans (“How”).
    • Should have strong understanding / hold in establishing Governance structure, including job allocation.
    • Deal with ambiguity, drive change management.
    • Strive to establish a Performance driven culture.
    • Strong focus on people development (viz. Skill development, Coaching, Mentoring).
    • Shall be strong communicator to establish mutual expectations within the team.
    • Periodically evaluate team members, provide and receive feedback in constructive manner.
    • Resource planning based on deliverables.
    • Establish performance metrics for measurement, comparison, or evaluation of factors affecting the QA and QC.

    Skill, leadership qualities

    Strong knowledge of GMP, Understanding of manufacturing processes, Lean Manufacturing, excellent verbal and written communication skills, excellent interpersonal and negotiation skills, , with a proven ability to create and maintain positive working relationships with all internal and external stakeholders (viz. suppliers, customers), strong supervisory and leadership skills, excellent organizational skills and attention to detail, thorough understanding of relevant statutory requirements, strong analytical and problem-solving skills, learning agility.

    Command, Composure, Dealing with Ambiguity, Decision Quality, Managerial courage, written communication

    Minimum qualification and experience

    • Bachelor’s / Master’s degree in Pharmacy or any Master’s degree in Chemistry or any other relevant degree.
    • Preferred certification on Negotiation.
    • Overall minimum 12 years of experience in QA, QC and preferably Production.
    • Minimum 5 years of experience as a manager, or similar relevant position required.

    Position reports into: Solid line reporting to Global QA Head for the Cluster, Dotted line reporting to Managing Director of the plant.

     

    Position – Site Quality Head                                                                     Local Designation: Associate Director

     

    Technical

    • Ensure maintenance of the licence to continue operation (including implementation of Global Quality Standards in the Site e.g. cGxP and management of Audit and Self Inspection; monitoring of KPIs relating to quality and taking corrective actions; leading Quality Review Board)
    • Ensure timely and quality delivery of product to market (release of batches) according to Regulatory Files and HA Requirements and Customer Expectations; Managing effectively product recalls and customer complaints as required
    • Ensure management of site quality control activities (acceptance, quarantining or rejection of incoming raw materials and components, in-process tests and inspections).
    • Ensure management of analytical development (method development, method validation, specification generation, method transfer, new QC technologies Pharmacopoeia review, troubleshooting)
    • Lead the QA organization to meet its objectives and deliverables (performance, development, organizational design, capability building, budget etc) as well as developing a Quality culture and mind-set across the Site.
    • Accountable to ensure that the Implemented QMS is completely aligned with the Corporate Policies/ SOPs, in compliant with all Rules, applicable laws and conditions mentioned in the Licenses (viz. Manufacturing license, Test license, GMP license, etc.) and fully meeting the expectations of Health Authorities (and applicable schedules, guidelines) relevant to the dossiers.
    • Focal point of contact for all Health Authorities and Lead all Health Authority Inspections.
    • Lead a cross functional team to identify Risks (in proactive manner) associated with QMS and mitigate the risks/ reduce the risk to acceptable level.
    • Conceive and drive Quality improvement plans in structured manner.
    • Partner with SCM to develop new Supplier, create Key Supplier Management program for existing supplier.
    • Create a strong oversight on all QMS related matters within the site.
    • Lead Analytical tech transfer and ensure a robust process and analytical method is transferred at site.
    • Guide cross functional team for an effective Investigation, root cause analyses and define appropriate CAPA.
    • Support / deliver / perform all relevant review and approvals of layouts, various documents related to new Product introduction in new facility.
    • Accountable for driving the QC instrument selection, installation and qualification.

     

    Managerial

    • Should have in-depth knowledge on defining &/or aligning Objectives (with N+1), with clear measurables.
    • Should be able to translate all Objectives (“What”) into actionable plans (“How”).
    • Should have strong understanding / hold in establishing Governance structure, including job allocation.
    • Deal with ambiguity, drive change management.
    • Strive to establish a Performance driven culture.
    • Strong focus on people development (viz. Skill development, Coaching, Mentoring).
    • Shall be strong communicator to establish mutual expectations within the team.
    • Periodically evaluate team members, provide and receive feedback in constructive manner.
    • Resource planning based on deliverables.
    • Establish performance metrics for measurement, comparison, or evaluation of factors affecting the QA and QC.

    Skill, leadership qualities

    Strong knowledge of GMP, Understanding of manufacturing processes, Lean Manufacturing, excellent verbal and written communication skills, excellent interpersonal and negotiation skills, , with a proven ability to create and maintain positive working relationships with all internal and external stakeholders (viz. suppliers, customers), strong supervisory and leadership skills, excellent organizational skills and attention to detail, thorough understanding of relevant statutory requirements, strong analytical and problem-solving skills, learning agility.

    Command, Composure, Dealing with Ambiguity, Decision Quality, Managerial courage, written communication

    Minimum qualification and experience

    • Bachelor’s / Master’s degree in Pharmacy or any Master’s degree in Chemistry or any other relevant degree.
    • Preferred certification on Negotiation.
    • Overall minimum 12 years of experience in QA, QC and preferably Production.
    • Minimum 5 years of experience as a manager, or similar relevant position required.

    Position reports into: Solid line reporting to Global QA Head for the Cluster, Dotted line reporting to Managing Director of the plant.