Galderma is the emerging pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ - the skin - meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin, we are in shapes our lives, we are advancing dermatology for every skin story.
We look for people who focus on getting results, embrace learning and bring a positive energy. They must combine initiative with a sense of teamwork and collaboration. Above all, they must be passionate about doing something meaningful for consumers, patients, and the healthcare professionals we serve every day. We aim to empower each employee and promote their personal growth while ensuring business needs are met now and into the future. Across our company, we embrace diversity and respect the dignity, privacy, and personal rights of every employee.
At Galderma, we actively give our teams reasons to believe in our bold ambition to become the leading dermatology company in the world. With us, you have the ultimate opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.
Requirement
Education/Training:
- Bachelor’s degree in pharmacy.
Work Experience:
- Minimum six years’ experience in the pharma industry, acquired in Quality Assurance departments.
- Experience in pharmaceuticals, cosmetics and medical device
- Good skill and experience for handling of customer complaints, Deviation and QMS management.
- Be familiar with GDP, ISO9001, ISO13485 requirements and internal audit.
- Well verse with Excel, MS Word & Powerpoint, Trackwise, PATH & eDMS
Required pre-requisites skills for this position:
- awareness of the local regulatory Guidelines and Corporate Standards and applicable laws,
- Expert in presentation preparation & delivery
- Analytical skills
- Good, positive and proactive communication skills, English.
- commitment to continued improvement in department processes and performance.
Duties
and
Responsibilities
Main Responsibilities
- Designated as Responsible Person (RP) for ensuring Good Distribution Practice (GDP) in complied with for products imported and wholesaled by Affiliate.
- GMP responsible person for the Affiliate as applicable
- Handling of customer complaints, processing the case in Trackwise and work / ensure compliance in accordance with respective SOP.
- Perform quality and compliance specific tasks including but not limited to end to end management of customer complaints, lias with customer care teram, internal stake holders , review of information about secondary packaging/redressing, ensure proper labelling of products at the distributor, and product recall coordination.
- Participate in the creation/update of local SOPs to reflect local practices in accordance with Corporate Policies and SOPs
- Implementing and maintaining the QMS to ensure that required processes are established and effective.
- Support in quality systems processes such as, but not limited to; internal audits/self-inspection, change control, management reviews, 3rd party vendor management, deviation management and CAPA
- Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff
- Maintenance, analysis and reporting of Quality KPIs
- Ensure local repackaging of products is performed in accordance with specifications and required licenses.
- Review all packaging artworks from a local regulatory perspective as per internal / Corporate and local SOPs in place.
- Managing imported shipment, review of data loggers, and review all redressing artworks from a quality prospectives.
- Ensure proper system utilization for eDMS / PATH / Trackwise/Smartcockpit- participate as admin for mentioned software.
- To Support cross functional team in review and approval of GMP documents
- Execute assigned task by line manger on time-to-time basis.
