Stability Scientist

Job description

·  Job facts

Stability Scientist (12 month contract)

Core Responsibilities

·  Perform Post-launch stability testing as per the Stability Schedule.
·  Perform ad hoc stability testing as and when required for troubleshooting and investigation purposes.
·  Compile real-time stability plans and reports.
·  Address stability related queries in a timely manner.
·  Investigate stability failures including leading/participating in RCAs.
·  Assist in testing required for validation purposes.
·  Incorporate new products into the post-launch stability schedule.
·  Ensure that stability SOP's are updated when required and identify continuous improvement opportunities.
·  Ensure that where the need for procedures are identified they are communicated to the Manager.
·  Represent Stability in projects and/or meetings.

Training

·  Ensure that adequate technical training is provided to the stability team and business on all Stability related procedures and requirements in order to foster high-performance teams.

Audits

·  Participate in audits for post-launch stability and in regulatory and/or customer inspections.

Corrective Action

·  Active involvement in CR/NCR/CAPA/RCA process investigations related to stability.

Change Management

·  Ensure that any changes to the business that may affect Stability are risk assessed and, if implemented, tracked for additional Stability actions to take place following implementation.

Relationship

·  Establish, nurture and maintain good working relationships with internal and externalcustomer/stakeholdersthrough regular communication, networking and attending relevant meetings.

Team Culture and Performance

·  Build a team culture of excellence, exceptional work ethic, the superior quality of work and collaborative team spirit.

MINIMUM QUALIFICATIONS:

Formal Training/Education and Experience

·  Scientific degree. BSc Honours/Masters or equivalent qualification from a recognized tertiary institution in Molecular Biology, Biotechnology or another relevant biological/biomedical discipline.
·  1 to 2 years' Experience in Molecular Biology techniques, including PCR, qPCR and next-generation sequencing.

Knowledge, Skills, and Abilities

·  Knowledge of ISO Quality Management systems and Diagnostics would be advantageous.
·  Highly self-motivated, have excellent organization and able to communicate effectively at all levels in verbal and written form.
·  Willing and able to work independently and as part of a multi-disciplinary team.
·  Comfortable with change and be willing to establish and work towards the future vision of the organization.

Personal Skills

·  Drive to achieve, Attention to detail, Initiative, Planning & Organizing, Adaptable, Effective time management, Assertive.

Interpersonal Skills

·  Critical Thinking, Team player, Communication, Flexible.

TRAVEL REQUIREMENTS:

Possibly up to 5% of International Travel.

Roche is an equal opportunity employer.

Roche is an equal opportunity employer.
Quality, Quality > Quality Control

·  Who we are

At Roche, 98,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an equal opportunity employer.