Production Specialist

at  Bimeda

Reporting to Plant Manager, the Production Specialist is directly involved in ensuring that the manufacturing of products meets quality standards by performing detailed review of technical documents, batch card review in a timely manner and timely closeout of deviations, change controls and customer complaints as per cGMP requirements. In addition, the Production Specialist will participate in projects as assigned by the Plant Manager. The role will include coaching/training of technician’s and coordinator’s on maintaining a high level of RFT in the completion of operations GMP tasks.

EDUCATION:

• BEng/BSc degree in Engineering/Science or related field. Candidates with time served in a manufacturing environment with high level exposure to Quality Systems will be considered.

EXPERIENCE:

• 2+ years minimum in a similar role
• 2-3 years’ relevant factory-based experience in a regulated pharmaceutical industry in manufacturing environment with a high-level exposure to Quality systems
• Experience of hands on EHS activities co-ordination would be desirable.
• Experience in a non-sterile manufacturing/dispensing/packing environment is essential.
• Experience in a Liquid/Paste Manufacturing /Filling/Packing environment desirable.
• Experience interfacing with regulatory bodies advantageous

KEY ROLE SPECIFIC REQUIREMENTS:

• Plan and coordinate operations excluding calibration schedule in conjunction with Maintenance and Facilities Lead.
• Monitoring of the EMS for Airton Close warehouses, manufacturing areas and external storage units, weekly verification check and investigation of OOS.
• Ensure all batch documentation is reviewed in a timely and compliant manner.
• Raise and support the investigation and resolution of deviations, change controls, quality investigations, risk assessments, customer complaints as required.
• Investigate both individually and as a team member, product complaints, deviations, and OOS results to determine root cause and corrective/preventative actions. Assists in the preparation and execution of risk assessments.
• Maintain the GMP Files i.e. SOP, s, Batch Cards, packing Specs etc… for the Airton Close facility
• Open and close change controls in the Operations departments in a timely manner
• Generate and maintain the Production, Warehousing and Engineering Departments Training Matrices
• Develop learning programs and ensure all operations technician’s training is being completed and practical training is executed.
• Maintain Production and Warehouse PQR’s reviews in line with Quality’s requests.
• Continually review and update Production, Warehousing and Engineering SOP’s and Batch card review updates
• Perform QAD tasks as required.
• Perform weekly audits of the Airton Close Facility to ensure compliance with GMP and Safety regulations.
• Perform Environmental and Health and Safety Audits of the three facilities on a regular basis and carry out Health and Safety tasks as requested by the Plant Manager
• Monitors Operations systems i.e. Tier meetings, EHS systems, Production systems etc… and advises/presents to the Plant Manager on system performance; publishing metrics/reports regarding performance against set goals
• Lead or participate in continuous improvement/Compliance projects and activities to enhance GMP and Safety compliance, productivity and costs as requested by the Plant Manager.
• Coaching/training operators and co-ordinators on proper documentation practices on cGMP requirements
• Manage and participate in operations/production/warehousing/Quality related meetings on a daily/weekly/monthly etc… as requested by the Plant Manager
• Represent the operations department for all regulatory audits including internal audits, HPRA, EPA, HSA etc…
• Work on project teams and carry out project tasks as requested by the Plant Manager/ Project Manager running the individual projects. Take an active part in all relevant site projects across the different facilities.
• Deputize for the Production Management in periods of absence.

COMPETENCIES REQUIRED FOR THE ROLE:

• ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this
• EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
• FLEXIBILITY/OPENMINDEDNESS -The ability to be open to different and new ways of doing things; willingness to modify one’s preferred way of doing things. Is able to see the merits of perspectives of others than his/her own
• INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
  THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work ad information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled