Specialist, Deviations

2 weeks ago

Mississauga, Canada Resilience Full time

COMPANY SUMMARY:
RESILIENCE is creating the first sustainable ecosystem for advanced biopharmaceutical manufacturing. We’re building a robust, dynamic, and diverse network of manufacturing capability and talent - investing in innovation every step of the way.

We provide high-tech, end-to-end manufacturing and development solutions to ensure the medicines of today and tomorrow are accessible to all in need. This includes complex medicines, such as cell and gene therapies, viral vectors, and vaccines; as well as proteins and the next generation of medicines.

RESILIENCE believes in access to quality and innovation for all. Our adaptive facilities serve partners big and small. We continuously invest in R&D for next generation manufacturing and development, freeing our partners to focus on the discoveries that impact lives.

We offer customized and scalable processes, the highest quality and regulatory capabilities, and world-class facilities. Through manufacturing that’s faster, more flexible, and less risky, we safeguard the quality of critical medicines and protect the resilience of a vital supply chain.

JOB SUMMARY:
The Deviation Specialist (Specialist) will play an important role in the department by writing deviations, participating in Out of Specification analysis investigation, closing batch documentation prior to release and communicating with internal stakeholders/SME and client. In addition, the Specialist will act as a point of contact between the manufacturing group, QA/client QA and regulatory agencies.

MAJOR RESPONSIBILITIES:
Authors deviations, Investigations, Environmental Monitoring Excursion and CAPA for Manufacturing (USP/DSP/Fill/Finish//Buffer and PST) including but not limited to investigation handling, leading corrective and preventive actions (CAPA) and tracking batch release items to meet company targets.-
- Participates and applies Root Cause Analysis (RCA) tools and ensures CAPAs are implemented to eliminate deviation re-occurrence-
- Works closely with department manager and QA to support batch release activities while ensuring investigations comply with quality system requirements.-
- Actively participates in regulatory, client and internal audits by compiling and providing information to department manager.-
- Ensures Deviations are closed within assigned timelines to meet client demand and company targets.-
- Participates in data gathering and analysis for Monthly and Quarterly quality matrix as well ad departmental KPI.-
- Ensure adherence to GDP, GMP, and safe practices at clinical and commercial scales.-
- Implement process improvement related changes.-
- Ensure corrective and preventative action that have been implemented are effective via Effectiveness Checks (EC)-
- Provide support in ensuring batch readiness action items are completed prior to batch start-
- Performs all other job-related duties as assignedMINIMUM QUALIFICATIONS:
TECHNICAL KNOWLEDGE / EXPERIENCE:
Diploma with 3+ years or a B.Sc. with relevant industrial experience in pharmaceutical practices.-
- Demonstrate ability to perform RCA investigations and lead CAPA initiatives.-
- Demonstrate ability to review manufacturing, engineering, and quality documentation.-
- Strong working knowledge GMP requirements.PREFERRED QUALIFICATIONS:
Experience in top-tier biopharmaceutical environment-
- Knowledge of regulatory agencies HC, FDA and others.BEHAVIOURAL:
Teamwork: Working effectively and productively with others
- Independence: Ability to work with mínimal supervision
- Flexibility: Agility in adapting to change
- Written Communication: Writing clearly, succinctly and in a manner understood by the target audience.
- Problem Solving: Anticipating, analyzing, diagnosing and resolving problems
- Goal Orientation: Energetically focusing efforts on meeting a goal, mission or objective
- Interpersonal Skills: Effectively communicating, building rapport and relating well to all personality types
- Diligence: Attention to detail.
- This job profile provides an overview of the minimum requirements of the _
- job_
- and does not include all of the duties inherent, included or associated with the job or with the performance of the job. The _
- Company_
- reserves the right to make changes to the job profile as it sees fit to meet_
- the needs of the organization._
- NOTE: All employment is conditional upon the completing and obtaining a satisfactory background check, including pre-employment medical (where applicable), educational, employment, references, and criminal records checks (for which a pardon has not been granted).
- Resilience Biotechnologies Inc. (RESILIENCE), is committed to providing accessible employment practices that are in compliance with the Accessibility for Ontarians with Disabilities Act (AODA). Requests for accommodation can be made at any stage of the recruitment process. Applicants are asked to make their needs/requirements known to Human Resources.

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