WILHELM HAUFFMANN & COMPANY PTE. LTD.
Wilhelm Hauffmann is wholly owned subsidiary of Borden Eagle Singapore Pte. Ltd. for various consumer healthcare products (www.eaglebrand.com.sg and www.caplang.com)
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.
In view of the business expansion, we are looking for assistant manager/manager who has Quality Management/Product Innovation & Development (PID) experience to join our team :
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 post-audit follow-up 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 ad-hoc 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 problem-solving skills, time management and result-driven.