Position Purpose:
Is part of the Sandoz Development Center (SDC) project teams, provides quality compliance support and guidance to the Development Project Management respectively the project teams, performs document reviews, supports the supplier evaluation, establishes Quality Agreements and is part of the due diligence team, acts as quality person in the plant for the production of non-commercial batches, supports the dossier review and respective product launches. Assists with reporting of KQIs and Quality Metrics to SDC and Global Quality Management and supports regarding other SDC Quality Compliance activities such as self-inspections and external audit plan preparation as necessary.
Is part of the Sandoz Development Center (SDC) project teams, provides quality compliance support and guidance to the Development Project Management respectively the project teams, performs document reviews, supports the supplier evaluation, establishes Quality Agreements and is part of the due diligence team, acts as quality person in the plant for the production of non-commercial batches, supports the dossier review and respective product launches. Assists with reporting of KQIs and Quality Metrics to SDC and Global Quality Management and supports regarding other SDC Quality Compliance activities such as self-inspections and external audit plan preparation as necessary.
Major Accountabilities:
Participates in all project team meetings to provide quality compliance support and guidance to the project team. Defines the project quality tasks and quality standard for the project. Oversees the product development from a quality perspective. Participates in due diligence visits/ audits at suppliers/ CMOs/ CROs. Evaluates their quality standard and availability of a local manufacturing license. Is on the ground for the production of non-commercial batches (e.g. technical batches and registration/ validation batches) and in this regard cooperates/ aligns with the Quality organization of the Contract Manufacturing Organization (CMO) or any other Sandoz/Novartis network Technical Operations Site Reviews and approves, if necessary rejects, the respective quality documents of the projects, e.g. Master Batch Records, executed batch records, other manufacturing documents, Process Validation documentation, Method Validation Protocols/ Plans and Reports, Stability documentation, study protocols and reports regardless if these documents are internally and externally created. To do so requests associated data such as analytical test results, water testing data, environmental monitoring data (as applicable) regardless of the format of the data (charts, forms, print-outs). Reviews OOSs, Deviations, CAPAs, Change Controls in relation to the development projects. Verifies that all excursions from written procedures have been documented and explained according to the respective quality incident reporting procedure(s). Disposes each batch of registration product manufactured by CMOs or SPC and therewith cooperates with the relevant Quality function at the CMOs or SPC. Preparation of product launch - support of Pre-Approval Inspection (PAI) and definition of CMO preparation programs for PAI. Supports the creation of audit plans for both internal and external audits. Supports self-inspections to assess the current general compliance status of the Development Center with GMPs and relevant corporate policies Supports the issuing of self-inspection reports and informs SDC Leadership Team immediately of any significant issues found during the inspection. Immediately escalates quality and compliance issues to SDC Quality Management.
Participates in all project team meetings to provide quality compliance support and guidance to the project team. Defines the project quality tasks and quality standard for the project. Oversees the product development from a quality perspective. Participates in due diligence visits/ audits at suppliers/ CMOs/ CROs. Evaluates their quality standard and availability of a local manufacturing license. Is on the ground for the production of non-commercial batches (e.g. technical batches and registration/ validation batches) and in this regard cooperates/ aligns with the Quality organization of the Contract Manufacturing Organization (CMO) or any other Sandoz/Novartis network Technical Operations Site Reviews and approves, if necessary rejects, the respective quality documents of the projects, e.g. Master Batch Records, executed batch records, other manufacturing documents, Process Validation documentation, Method Validation Protocols/ Plans and Reports, Stability documentation, study protocols and reports regardless if these documents are internally and externally created. To do so requests associated data such as analytical test results, water testing data, environmental monitoring data (as applicable) regardless of the format of the data (charts, forms, print-outs). Reviews OOSs, Deviations, CAPAs, Change Controls in relation to the development projects. Verifies that all excursions from written procedures have been documented and explained according to the respective quality incident reporting procedure(s). Disposes each batch of registration product manufactured by CMOs or SPC and therewith cooperates with the relevant Quality function at the CMOs or SPC. Preparation of product launch - support of Pre-Approval Inspection (PAI) and definition of CMO preparation programs for PAI. Supports the creation of audit plans for both internal and external audits. Supports self-inspections to assess the current general compliance status of the Development Center with GMPs and relevant corporate policies Supports the issuing of self-inspection reports and informs SDC Leadership Team immediately of any significant issues found during the inspection. Immediately escalates quality and compliance issues to SDC Quality Management.
Candidate Profile
A bachelor's degree in life/ physical science such as chemistry, biology, microbiology, pharmacy, biochemistry. Ability to read and comprehend documents, instructions, and correspondence in English. Minimum 5 years of QA operations experience in a pharmaceutical, biologics or sterile products manufacturing facility. Ability to transfer knowledge and educate GMPs. Auditing experience and experience in handing inspections is a plus. Detailed knowledge of GxP, regulatory guidelines, and quality management Broad and in-depth understanding of drug product development and good understanding in the area of tasks and responsibilities within the SDC Adequate presentation and scientific/ technical writing skills Strong organizational and communication skills Knowledge of software and computer tools relevant for pharmaceutical development Experience in an international matrix organization Good interpersonal skills Inter-cultural savvy Self-motivated, process and performance oriented.
A bachelor's degree in life/ physical science such as chemistry, biology, microbiology, pharmacy, biochemistry. Ability to read and comprehend documents, instructions, and correspondence in English. Minimum 5 years of QA operations experience in a pharmaceutical, biologics or sterile products manufacturing facility. Ability to transfer knowledge and educate GMPs. Auditing experience and experience in handing inspections is a plus. Detailed knowledge of GxP, regulatory guidelines, and quality management Broad and in-depth understanding of drug product development and good understanding in the area of tasks and responsibilities within the SDC Adequate presentation and scientific/ technical writing skills Strong organizational and communication skills Knowledge of software and computer tools relevant for pharmaceutical development Experience in an international matrix organization Good interpersonal skills Inter-cultural savvy Self-motivated, process and performance oriented.
Additional Information
Experience : 5 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th March, 2018
Experience : 5 years
Qualification : B.Pharm, B.Sc
Location : Hyderabad, AP
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
End Date : 20th March, 2018
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