Assistant Manager R&D / Packaging Development
• 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.
- 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.
Terms of employment
• 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.
Marije Hoogendoorn | Senior Recruitment Specialist
Email : firstname.lastname@example.org
Telefone : +31 (0) 623 13 51 18