Quality Assurance Associate – MDS Pharma Services

Friday, January 9, 2009

Category: Jobs. Tags: Control & Testing / ISO, Jobs in Singapore, Life Science - Bio-Medical, Life Science - Others, MDS Pharma Services, Pharmaceutical, Quality Assurance.

Quality Assurance Associate MDS Pharma Services

MDS Pharma Services is a business unit of MDS Inc. (TSX: MDS; NYSE: MDZ), a global life sciences company that provides market-leading products and services that our customers need for the development of drugs and diagnosis and treatment of disease.

Due to our rapid expansion, we are looking for experienced and passionate professionals to join us.

Quality Assurance Associate

Position Summary:

The Quality Assurance Associate will be instrumental in leading MDS Pharma Services Central Lab operational departments in the context of the Quality Policy and Quality System. This will include review of SOPs, implementation of initiatives to address deficiencies, and participation in the establishment of a Quality Metrics Program as a member of the QA group. These efforts are directed to facilitate compliance by MDS Pharma Services Central Lab (MDS PS CL) with the necessary regulatory guidelines (e.g. FDA, TPP, ICH). This individual will also be required to interact closely with QA representatives at other MDS PS CL locations.

Qualifications:

University degree or equivalent.
Para-medical or medical background or biological knowledge.
5 years experience in Pharmaceutical Industry and/or Central Laboratory environment.
Knowledge of GCP (ICH, FDA, EMEA), CLIA and/or CAP and/or ISO, FDA 21 CFR 11 and other applicable regulations.

Skills and Knowledge Requirements:

Analytical, detailed oriented, well organized.
Intermediate administrative and computer skills.
Highly developed communication skills – both verbal and written
Demonstrated aptitude to work in an international environment.
Bilingual an asset (English + other language).

Key Responsibilities:

Knows and understands applicable global regulations and the Quality System and promotes awareness and compliance.
Participates in the organization Quality Objectives and provides direction regarding potential operational priorities.
Leads co-workers and delegates tasks appropriately to achieve project goals.
Monitors the review of Global and Local Standard Operating Procedures and encourages departments in process improvements. Acts as Global SOP Custodian.
Assists the staff where needed to ensure the writing, correction, implementation and revision of the Standard Operating Procedures.
Monitors the execution of SOP training sessions of new or revised SOPs in regard to content and presentation.
Coordinates and prepares for Client Audits i.e. audit scheduling, reservations, presentation of the Quality System Documentation.
Conducts Internal Audits of projects, departments, processes and subcontractors according to the internal audit schedule.
In following up on Internal Audits, initiates the development of new methods for quality improvement as needs arise and where possible.
Networks with operational departments on a regular basis to understand internal customer requirements and external customer feedback and develops recommendations in support of local and global QA Strategic Planning.
Participates in the review of documented Incidents and suggested corrective actions and implements appropriate QA initiatives if necessary.
Participates in the management of Quality Metrics.
Ensures effective and appropriate communication for tasks and duties assigned, between different departments within the organization and between Global QA counterparts.
Follows the applicable Standard Operating Procedures.
Actively participates in internal departmental or external meetings , by taking lead roles in action items or initiatives.
Works with Computer System Validation colleagues on projects as required.

Interested applicant please e-mail your resume indicating salary (Expected/Last Drawn), earliest availability date, reasons for leaving for each past and current employment.

We regret that only shortlisted candidates will be notified.