Lowongan Novartis (Dibuka : 07 April 2013)
Informasi Detail Lowongan
|Head of Quality, South East Asia|
|Dibuka: 07 April 2013 - 1 tahun yang lalu|
Novartis memberikan persyaratan, ketentuan dan spesifikasi pekerjaan sebagai Head of Quality, South East Asia yang akan ditempatkan di Jakarta, Jakarta.
Dibawah ini rincian lengkap persyaratan, spesifikasi lowongan pekerjaan, jadual wawancara dan alamat serta kontak (email / nomor telepon) perusahaan Novartis. Untuk mengirimkan lamaran, klik pada tombol 'Kirim Lamaran Sekarang' dibawah.
Spesifikasi dan Persyaratan Pelamar Pekerjaan Novartis
As member of the India-South East Asia (ISEAP) operating unit, the Head of QA will provide Quality leadership across the unit and drive local implementation and maintenance of the Novartis Quality Management Systems for OTC in South East Asian markets, including Indonesia, Thailand, Philippines, Vietnam, Malaysia and Singapore. He/She will manage and coordinate the oversight of quality for all OTC products manufactured by local third party manufacturers and/or distributed in the assigned markets. The Head of QA is accountable to ensure adequate assessment and implementation of Novartis OTC standards and global procedures in accordance with Global and Corporate Novartis Quality policies. The Lead the development, maintenance and improvement of quality systems to support OTC business continuity in the Operating Unit. The incumbent acts as the single point of contact for the Novartis OTC Quality organization with all markets assigned.
The position will be based in Indonesia.
Building the Quality Systems
Business continuity & Management of Quality
- Implement the Novartis Quality Manual within the assigned cluster including applicable Quality Modules, Standard Operating Procedures, and Implementation Guidelines so that it is recognised by Novartis and by regulatory authorities in those countries as a quality committed company.
- Perform and lead the risk assessment programs at site, contractor and country level associated with existing Quality processes and systems within the markets assigned and provide recommendations and solutions to close gaps and ensure sustained compliance with the Corporate Quality Manual requirements.
- Monitor Third Party manufacturers and distributors within the assigned markets and ensure they comply with Novartis requirements, have appropriate QA agreements in place, and any CAPA resulting from Novartis Compliance & Audit group are tracked to completion.
- Drive completion of the corrective actions identified results of the risk assessments within the specified timelines.
- Lead the execution of all deliverables identified in the quality plan for the assigned markets
- Ensure APR/PQR process is managed in accordance with the quality manual requirements for all products manufactured by local TPO whenever applicable.
Quality Compliance and Monitoring
- Manage and supervise the duty of care release activities for the assigned markets. Perform the release function and hold the release authority for OTC product released in the assigned markets.
- Ensure all quality issues associated with the release process are investigated and documented according to the approved procedure.
- Manage the Change Control program to ensure that changes affecting marketed product are documented, evaluated and implemented per Novartis requirements.
- Manage the Deviation Management system including the CAPA program to investigate incidents and identify adequate corrective measures to prevent their recurrence.
- Manage the documentation management system (GEMA) to ensure procedures are up to date and accurate for their intended use.
- Develop, implement and maintain Raw Material, Packaging Components, Labelling and Finished Products specifications.
- Ensure all complaints are recorded, investigated and closed in a timely manner into the Global OTC complaints database. Ensure customer enquiries & complaints are regularly reviewed to identify opportunities for improvement.
- Approve stability and validation requirements/protocols/reports, QA investigations, and annual product reviews, procedures and GMP control documents.
- Maintain key quality performance indicators (KPI) for Third Party Organization in the assigned markets, including third party manufacturer and distributors. Perform periodic reviews and monitoring of the quality and/or compliance of OTC products distributed in the assigned markets.
- Provide data in support to the development of monthly reports and trend reports to meet periodic requirements for the Global and Regional Organizations (i.e. KPI, monthly reports, risk assessments etc.).
- Provide guidance to third party manufacturing sites, distributors and relevant OTC country organisations to minimize the compliance risk for Novartis products and to avoid or minimise duration of stock-out situations.
- Build partnerships and collaborate with key stakeholders in other areas of the business (GMS, Finance, Marketing), including but not limited to internal Novartis Quality groups (i.e. Global QA, regional QA) as well as external QA organization (contractors and third party organizations) when applicable.
- Manage the periodic quality reviews of quality and/or compliance performance of OTC products manufactured and distributed in the assigned market.
- Drive specific inquiries deemed necessary to assess exposure or compliance of Novartis OTC products within the assigned Operating Unit.
- Evaluate periodically the quality systems at the contract manufacturing sites and warehouses in line with Novartis third party assessment standards’ to ensure that the compliance gaps have been identified and adequate remediation plan are in place.
- Act as SPOC for QA on cross-functional business initiatives and projects in the region and/or for the global QA organizations. Minimum requirements Background
Graduate in Chemistry, Pharmacy, Biology, or related Science or discipline
Fluent English required with excellent communication and negotiation skills (oral and written). Knowledge of another language from the region a plus.
At least 8-10 years relevant experience in a regulated Pharmaceutical, Medical Device or Consumer Health industry including Quality Assurance, Quality Control, and/or R&D or Drug Regulatory Affairs.
Strong knowledge of Quality Systems with working knowledge of GMP requirements associated with pharmaceutical production (facilities, equipment, production processes, and laboratory controls)
Some hands on experience in a pharmaceutical manufacturing environment with demonstrated ability to interpret and implement international pharmaceutical GMP requirements. Possess a strong attention to details with record of driving quality performance in a commercial environment.
Experience in managing third party organizations, including warehouses and distributors.
Ability to implement Quality Systems while supporting the execution of day-to-day QA processes in support to the commercial operations.
Possess a strong attention to details with record of driving quality performance in a commercial environment while maintaining a quality-focused attitude.
Champions Novartis Values; especially quality and customer focus, leadership, flexibility to re-organise own use of time to face emergencies in the organisation.
Experience in working in an international and multidisciplinary environment.
Shows insight and good judgement in assessing complex or uncertain alternatives, including the risks of each. Considers impact of decisions on other part of the organization before making them.
Computer literate (Microsoft Office, Trackwise, Documentum) with demonstrated skills in the use of word processing, spreadsheets, databases & information management systems.
Prior experience in working in an international and multidisciplinary environment desired.
Willingness to travel internationally; sometimes at short notice
Travel time: 20-30 %.
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