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Job Description
Key Roles & Responsibilities:
* Supervise the manufacture defined cGMP procedures to deliver high potency ADC/API's in support of launched products and clinical trial programme.
* Proactive approach to suite readiness, structured monitoring, line clearance, BOM /Stock levels, sample control and SAP inventory.
* Takes on a key role with the introduction of new products, liaising and communicating with relevant departments on highlighted issues.
* Ensuring all team members are adequately trained and deliver training as and when required.
* Effectively utilise and motivate manufacturing team to obtain the required schedule adherence.
* Possess good verbal and written communication skills.
* Ensure that all GMP documentation is completed "real time" and accurately in the aim of right first time.
* Maintain high SHE Standards, carrying out all work in accordance with appropriate SHE systems.
* Ensure that 5's and housekeeping standards are adhered to, and suites are "audit" ready at all times.
* Raise any deviations and REW's as required. Progress any investigations, CAPA's to completion through "Trackwise" within the stated timeframe.
* Leads continuous progress within the suites.
* Deputies for Shift Team in their absence.
Key Competencies:
* Teamwork: The ability and desire to work cooperatively with others on a team.
* Communication: The ability to ensure that information is passed on to others who should be kept informed.
* Building Collaborative Relationships: The ability to strengthen partnerships with others inside the organization who can provide information, assistance, and support.
* Attention to Detail: Ensuring that one's own and others' work and information are complete and accurate.
* Personnel Credibility: Demonstrated concern that one be perceived as responsible, reliable, and trustworthy.
* Forward Thinking: The ability to anticipate the implications and consequences of situations and take appropriate action to be prepared for possible contingencies.
* Interpersonal Awareness: The ability to notice, interpret, and anticipate others' concerns and feelings, and to communicate this awareness empathetically to others.
* Customer Awareness: The ability to demonstrate concern for satisfying one's external and/or internal customers.
Qualifications
Essential Qualification:
* Degree in a scientific subject or the equivalent GMP experience.
* Possess good verbal and written communication skills.
Essential Experience:
* Good chemical/bio-processing industry knowledge.
* Good working knowledge of GMP.
* Understand chemical unit operations and process chemical reaction hazards.
* Possess good verbal and written communication skills.
* Experience of working in clean rooms (desirable).
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