Cache of job #13765802

Job Title

Manufacturing Process Specialist - Normal

Employer

Independent Solutions

Location

Cork

Description

Our client based in Cork is seeking the following: JOB DESCRIPTION OF THE MANUFACTURING PROCESS SPECIALIST NORMAL. Purpose. To define the authority, duties and responsibilities of the Business Unit. Specialist. Scope. This Job Description applies to the position of Business Unit Specialist at. Janssen Pharmaceutical, Little Island, Cork. Definitions. GMP Good Manufacturing Practices. EHS Environmental , Health and Safety. SOP Standard Operating Procedure. NCP Non Conforming Product. Responsibilities. Supervisor. Business Unit Manager. Duties and Responsibilities. As a core member of the business unit the Business Unit Specialist is. responsible for providing technical support to the business unit in. ensuring efficient manufacturing while ensuring compliance with GMP, EHS standards at all times. Responsibilities include: € Development of new and revised manufacturing and cleaning recipes in. line with Master Batch book requirements. € Preparation of Process & Cleaning Validation protocols and reports as. required by the business unit and coordination with other business unit. partners to ensure all other validation requirements are met in line with the. Site Validation Master Plan (e.g. analytical validation. € Completion of any Equipment & Computer system Qualification as. required by the business unit. € Production of Annual Product Review reports for all products relating to. the business unit. € Development of and subsequent reporting on metrics relating the overall. end to end performance of the business unit including the preparation of. scorecards, dashboard and data for management review. € Management of deviations (including customer complaints, EHS incidents, NCPs etc) to ensure timely investigation, root cause analysis and. implementation of corrective and preventive actions. € Management of the manufacturing related aspects of the Change Control. system in line with site procedures. € To participate in HAZOP studies so that potential problems are identified. and designed out of processes. € Identification of opportunities for improvement within the manufacturing. process through trend analysis and continuous review of all operations. (e.g. completion of Self Inspections/ Internal Audits/process Optimization. € Partnering with business unit personnel in the proactive identification of. innovative solutions to problems. € Develop re processing /rework strategies, test methods and protocols. € Attendance at operations meetings as required in support of the Business. Units. € This position description is a general guideline for colleagues; it does not. purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any. time, or to vary the duties and responsibilities of the position to meet. production, scheduling or other business needs. SIGNIFICANT SAFETY OR WORKING CONSIDERATIONS : Comply with the requirements of the company’s Environmental, Health & Safety. Policy, Safety Statement, associated EHS Procedures and duties outlined in the. Safety Health and Welfare at work Act. Job Function Competencies: The Competency of Personnel to perform their assigned functions is acquired by. appropriate Qualifications, Education, Training and Experience, (Knowledge & Skill. or any combination of these. On the job competency is determined by a set of. activities that each Employee must complete in order to carry out their functions. These are described as Skills profiles / Curriculum and are assigned through the site. LMS. Minimum Requirements. The position of Business Unit Specialist requires a third-level qualification in the. relevant field and/or 4 years experience in the industry. Authority. All functions associated with duties listed above. However, changes to existing or. implementation of new policies and procedures require the approval of the Director. of Manufacturing/ Business Unit Manager. Key Skills and Competencies required: • Excellent interpersonal skills. • Ability to operate as part of a team is critical. • Customer focus. • Innovative. • Mechanical/Technical aptitude. • Excellent communication skills both written and verbal. • Attention to detail. • Good problem solving skills. • Results and performance driven. • Adaptable and flexible Education and Experience: • A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering. • Understanding of the requirements of cGMP and familiarity with other relevant regulatory requirements. This job originally appeared on RecruitIreland.com.

Date Added

2469 days ago

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