Key Responsibilities:
- Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re-enforce in meetings, perform periodic field observation and feedback as needed.
- Lead a team as the system owner in preparing and executing Biopharmaceutical Process Equipment C&Q documents, ensuring achievement of the project schedule, track and report progress to the C&Q Manager.
- Provide a strong working technical knowledge of Biopharmaceutical Process Equipment systems regarding the development of protocols, their execution, and close out.
- Provide technical oversight to a Biopharmaceutical Process Equipment C&Q team to assure technical work quality, consistency, and alignment with the C&Q programme.
- Work in the Kneat platform for preparation, review and approval of C&Q documentation with a key focus on traceability to User Requirements throughout.
- Coordinate with the Engineering Compliance team, the QA team and other stakeholders in assuring all decisions on the document preparation for Biopharmaceutical Process Equipment systems are aligned and agreed.
- Work collaboratively with the other project disciplines (e.g. automation, construction, engineering, end user) to support integration of activities.
- Train Biopharmaceutical Process Equipment personnel on the C&Q programme and it’s implementation in execution
- Report on any proposals for deviating from the C&Q program during doc development and execution to ensure they are addressed and, if agreed on, documented in a timely manner.
- Report issues for escalation where agreed document review and approval (pre and post, where applicable) turnaround times are not being adhered to.
- Report issues for escalation where agreed execution timelines are not being adhered to.
- Report any other issues which need to be escalated when no resolution is clear with the stakeholders internally.
Qualifications and Requirements:
- 8 years minimum C&Q execution experience in the pharmaceutical sector with a minimum of 1 in a C&Q execution leadership role.
- Degree in engineering (M. Sc. / B. Sc.) or equivalent
- Demonstrated leadership and people management skills.
- Knowledge of GMP’S, regulatory requirements, equipment commissioning and qualification.
- Ability to work well in a team environment.
- Able to manage multiple parties and coordination.
- Proficient in the use of DeltaV.
- Proficient in the use of Kneat.
Top Skills
What We Do
Unison Consulting was launched in Singapore on September 2012, the hub of the financial industry, with innovative visions in the technocratic arena. We are a boutique next-generation Technology Company with strong business-interests in Liquidity risk, Market Risk, Credit Risk and Regulatory Compliance.
Unison provides technology consulting and services to implement Risk Management and Risk Analytics System for Financial Institutions. Our services suite comprises of Techno-Functional consulting, systems integration, Business Intelligence, information management, and custom development of IT solutions, plus project management expertise for financial institutions.
We have expertise in latest cutting edge technology to achieve better total cost of ownership. Through our qualified professionals, we assist you drive your unique risk management strategies, whether that means efficient monitoring, improving risk appetite of the financial institutions, complying with regulations, or capturing growth opportunities through innovation, this is what maximizes your decision taking potential. At Unison Consulting, we view clients as partners, and our success is only measured by the success of our partners. So we put it all on the table in order to exceed expectations.
Our staff consists of young, energetic and innovative consultants who are never afraid to challenge the conventions and push the boundaries in an effort to help our clients. For every project, no matter how large or how small, we strive to not only meet your needs, but deliver a showcase in your field
