About the job
Operations Technical Support Specialist (S3):
Job Title: Operations Technical Support Specialist
Department: Operations Technical Support
Position Reports to: Operations Technical Support Lead
- Be recognised as Process Subject Matter Expert which will be supported through dedicated training and development opportunities.
- Strong experience in Parenteral /Aseptic Manufacturing process.
- Development and execution of Continuous Improvement (CI) projects which will be supported with Lean Six Sigma Training and certification.
- Support CI process by attending CI meetings and leading CI as required.
- Provide day to day technical support to the parenteral manufacturing unit in addition to exposure to network based initiatives.
- Lead Audit Preparation and audit support for your area.
- Provide day to day operations and compliance support.
- Be proactive in error proofing and aiming to prevent human errors and events.
- Support the operating unit in preventing investigations to enable timely disposition.
- Provide operations support for projects in your area of expertise.
- Own and lead investigations pertaining to your particular focus area.
- Identify and implement SMART CAPA’S that error proof and drive down repeats and overall deviation reduction for the suite.
- Identify, and implement improvements to, recurring process and procedural inefficiencies that do not necessitate event reports.
- Technical input to developing and optimizing work processes (SOPs etc.) within your area of expertise. Lead revisions to these documents as required.
- Act as the point of contact for introduction of procedure and document changes including: red-line procedures for improvement; review procedural revisions prior to implementation, prepare and deliver training for new documents and revision training and re-training.
- Own operations commitments / change controls / interfacility and vendor complaints / action items within your area of expertise.
- Support the Medical Device Combination Product (MDCP) CAPA process in Parenterals.
- Proactive & effective communication within and across shifts.
- Proactive engagement with key stakeholders at senior level within the business.
- Engage with partners in based in other Pfizer sites to establish a technical forum of practice.
- Demonstrate the Pfizer GC Culture and Values
- Personal Development plans focus on the 70:20:10 guidelines
- Adhere to all HR Policies as appropriate
- Third level Qualification in Science, Engineering or equivalent is preferred. Exceptions may be considered where relevant skills/experience and correct attitude and behaviors exist (this may be supplemented by further education in parallel).
- Experience in a Biopharmaceutical or Pharmaceutical cGMP-manufacturing environment essential.
- Experience in operating within a regulated environment (EMEA, FDA).
- Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.
- Proven technical writing skills in the completion of complex investigations.
- Demonstrated aptitude for technical learning and problem solving.
- Proficient understanding of aseptic process manufacturing. Previous experience with formulation, aseptic filling and / or automated visual inspection highly desirable.
- Experience in leading investigations to closure identifying true root cause and effective CAPA’s is preferred.
- Previous experience with systems such as an electronic document management system (PDocs), QTS, SAP, MCS and MES highly desired.
- Demonstrated ability to lead, influence, and train others.
- Demonstrated ability to lead method 1’s and troubleshooting with a cross functional team.
- Excellent interpersonal and communication skills.
- An ability to deal with process change and implement new effective processes.
- An ability to work through peers and across organizational boundaries and influence at all levels in the business.
- An ability to think analytically and innovate to achieve goals.
- This job description indicates the general nature and level of work expected of the incumbent. It is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required of the incumbent. Incumbents may be asked to perform other duties as required.
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