Manager - Quality Assurance - Pharma

Role Overview Lead and manage activities related to Quality Assurance. Maintain the local Quality Management System and monitor its compliance status. Contribute proactively as an effective leader, functioning responsibly and autonomously while working within the framework of internal and external regulatory guidelines and procedures.

Job Requirement

- Education: Bachelor of Science Degree in Pharmacy or Life Sciences

Work Experience:

- Minimum five years' experience in the bio/pharma industry, preferably acquired in Regulatory Affairs or Quality Assurance departments

- Experience in cosmetics, prescription, OTC and medical devices products

- Good skill and experience of customer complaints and audit

- Has experience and practice associated with quality management IT systems like Trackwise, etc

- Be familiar with GMP, GDP, ISO9001, ISO13485 and daily work in QA and implement drug product Regulations/Law and GMP/GDP requirements; provide effective quality management.

Required pre-requisites skills/experience for this position:

- Good knowledge of regulated products and the country/regional regulations and governmental authorities

- Able to read, write and speak English fluently

- Thorough knowledge of the local regulatory Guidelines and Corporate Standards and applicable laws.

- A good understanding of the commercial drivers of the life science industry and an associated ability to provide advice/guidance that takes these into consideration

- Analytical skills

Skills & Attributes Requirement :

- Ability to practice and techniques related to web merchandising or online retailing.

- Expert communication skills, both verbal as well as written

- Flexible to changing conditions and possessing high level of integrity

- Expert knowledge of various business principles such as marketing strategy, financial analysis, and supply chain oversight

- Expert understanding of different technological components of online commerce

- Knowledge of database creation, search engine optimization tactics, data mining, and security issues

- Good, positive and proactive communication and the ability to foster excellent working relations with external customers including the health authorities, industry associations and internal stakeholders

- Skills such as project management, problem solving, ability to present information in easily understood format at internal and external meetings, good time management, negotiation and interpersonal skills

- Ability to work both independently or as part of a team as required

- Be proactive, motivated and a self-starter

- Be able to balance company commercial needs with achieved compliance

- Ability to think strategically and innovatively for resolution of quality issues

- Commitment to continued improvement in department processes and performance

- Strong team player, assisting others with workload peaks and the management of challenging situations

- Proactively contributes to a positive team attitude and highly productive work environment

Roles & Responsibilities :

- Designated as Responsible Person (RP) including maintaining Importer's and Wholesaler's License where applicable

- Responsible for ensuring Good Distribution Practice (GDP) is complied with for products imported and wholesaled by Affiliate

- GMP responsible person for the Affiliate when applicable

- Product complaints management

- Perform Quality and compliance specific tasks including but not limited to processing product complaints, 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

- Process owner of quality systems such as, but not limited to; internal audits/self-inspection, change control, management reviews, deviation management and CAPA

- Facilitate the process of analytical testing leading to the timely clearance of imported goods when required

- Compile and update training manuals, undertake induction training and refresher training related to QMS for local affiliate staff

- Ensure quality agreements are established with affiliate 3rd parties

- Ensure affiliate 3rd parties are qualified and maintained in an approved audit status

- Ensure product samples are authorized with maintained traceability and product integrity

- Decision of disposition for trade returns and damaged products

- Authorization of any product from quarantine to approved product status

- 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 and Corporate and local SOPs in place.

- Develop and manage effective working relationships with competent authority and Galderma Global colleagues

- Foster and maintain good cross-functional working relationships with other departments; attend cross-functional meetings and represent the Affiliate where necessary

- Represent the company in the relevant committees of the professional/industry associations, if necessary