Quality Management/product Innovation
2 weeks ago
WILHELM HAUFFMANN & COMPANY PTE. LTD.
The company main activities are in research and development (R&D) of consumer healthcare products, intellectual property (IP) holder (trademarks, patents and formularies), regulatory affairs (RA), technical compliance and business development in licensing the IP.
Roles & Responsibilities
- Assist to work along with internal and external units towards achieving common strategic technical goals.
- Develop, implement, and promote quality policies and procedures to ensure compliance with industry standards (cGMP, GDP, IFRA, etc).
- Develop, implement and enforce compliance standards and quality governance programs including regular audit / random checks / data analysis on contract manufacturing sites and ensure proper postaudit followup actions.
- Liaise with contract manufacturing sites to establish quality requirements, address issues and provide guidance on solutions and issue resolution.
- Manage harmonization of quality control standards of raw materials, packaging material and finished goods across manufacturing sites.
- Support certification audits with regulatory agencies and certification process across the region (US FDA, Health Canada, TGA, etc).
- Provide support in working with the business units on product innovation and development (PID) requirements, review and evaluate together with the technical team on the regulatory aspect/product concept/formulation/data analysis.
- Manage adhoc projects and tasks assigned by the management.
Requirements:
- Possess a good degree in pharmacy, bioscience/applied chemistry or equivalent from established university.
- At least 3 years of manufacturing related experience (e.g. production / quality assurance / quality control) preferably in the pharmaceutical line or related industry.
- Knowledge of quality procedures and guidelines in Asia Pacific countries is preferred. Additional knowledge of US FDA, EMA and ICH quality framework is an advantage.
- Good documentation and project management skill.
- Communicate openly with all stakeholders, embrace diversity of thoughts, create trustful relationships, lead and collaborate with willingness, fairness and integrity.
- Familiar with risk management tools/principles.
- Some exposure in PID and/or legal agreement matter is an advantage.
- Other core competencies i.e. good interpersonal skills, effective influencing, decision making and problemsolving skills, time management and resultdriven.
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