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Assistant Manager R&D / Packaging Development

Locatie

Taiwan (Nantou)

Bedrijfsprofiel

Founded in 1966, Lotus Pharmaceuticals (Alvogen APAC) is a leading generic company headquartered in Taiwan with comprehensive product portfolio covering CNS, CVS, oncology, women health, and anti-obesity drugs in tablets & hard/softgel capsules. Lotus runs the only plant in Taiwan approved by US FDA, EU EMA, and Japan PMDA. The Company started a new phase of growth in 2014 when Alvogen, a next generation, global pharmaceutical company, became a majority shareholder and hand picked Taiwan as its Regional Asian Headquarters. Lotus now is a fast growing specialty generic company in Asia. Their business model ensures competitive advantage through focused in-house capabilities and a network of partners for enhanced speed and flexibility. Through its majority shareholder Alvogen, Lotus has access to markets in the USA, Central Eastern Europe and Asia, while on its own Lotus has presence in Asia in Korea, Taiwan, China, India and exports to Japan and South East Asia.

Functieomschrijving/taken

Primary responsibilities of this role include the following:
• Responsible for Packaging Development of Generic Formulations for Global Markets.
• Responsible for Preparation and Management of Packaging Related SOP’s as per cGMP regulations.
• Responsible for Management of availability of Packaging Material for Development Trials, Submission and Validation Batches.
• Responsible for Preparation of Packaging Development Report.
• Responsible for Preparation of Batch Packaging Records and Packaging Reports for Submission and Validation Batches
• Responsible for Identification and Alternate Source Packaging Material Development of Approved/Under Approval Generic Products.
• Responsible for Packaging Technology Transfer to In-house and CMO sites including Support for Trouble Shooting in Launch/Commercial Batches.
• Responsible for query response from regulatory and cross functional teams.

Profiel kandidaat

  • Minimum seven years’ experience in Pharmaceutical Packaging out of which at least Three years in Research and Development.
  • Knowledge of Brand Pack Evaluation and Reverse Engineering of Packaging Components of Brand.
  • Hands on experience on Bottle and Unit Dose Packing of Oral Solids in compliance to Global Regulatory Requirements (USFDA, EMEA, ANVISA, PMDA etc)
  • Familiar with implementation of Child Resistant Features in Bottle and Unit Dose Packs.
  • Must have knowledge about investigations, Change control, Deviation and CAPA
  • Knowledge on development of commercial Artworks and Serialization would be optional.
  • Excellent Oral and Written Communication to cater extensive communication with Cross Functional Teams Globally.

Arbeidsvoorwaarden

BENEFITS
• Exposure to Global, Multidisciplinary and Multilocational teams to enhance soft skills.
• Exposure to handle Multiple Products with Varied Category to enhance professional Skills.
• Relocation to Taiwan will be supported and remuneration is accordingly.

Contactpersonen

Marije Hoogendoorn | Senior Recruitment Specialist
Email : hoogendoorn@themagroup.nl
Telefone : +31 (0) 623 13 51 18

Tagcloud Assistant Manager R&D / Packaging Development

packaging development - generics - pharmaceuticals - Alvogen - Taiwan
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