The selected candidate will be responsible for providing subject matter expertise in the Operations area (Packaging & Aseptic Operations) belonging to the Operations Support Team. He/she will partner with shift operations teams. He/she will work as part of the operations support team facilitating the day to day operations function, leading and implementing continuous improvement projects. He/she will work proactively ensuring that the operations team is able to execute flawlessly in a Zero Defects environment, with a focus on preventing errors. He/she will lead the investigation of events and QAR's (Quality Investigations) within their area of expertise to closure.
Successful candidate will lead and manage all aspects related to the Quality Systems in the Manufacturing & Packaging Departments, Investigations -including corrective and preventive (CAPA) actions-, Change Control, Risk Management, Commitments, Documentation (SOP, Forms, MBRs (Master Batch Records)), CAS (Compliance Analysis Status) and area projects with the aim of preventing reoccurrence of deviations and improving process robustness. M1 methodology (Six Sigma) will be used to ensure proper root cause analysis. He/she will also work to anticipate potential deviations by analysis of process trends to proactively implement preventive actions that eliminate the potential for non-conformities to occur.
The incumbent will work with the Operations Management and Quality Assurance Operations to facilitate the consistent, disciplined execution of the quality systems ensuring the timely completion of activities related to Quality Systems.
The Operations Support team will be part of the PCT (Process Centric Team), giving support as process specialists (in Packaging and Aseptic Operations).
+ Be recognized as Process Subject Matter Expert, in the required operational area.
+ Provide technical, process understanding and expertise in support of complex technical investigations and process troubleshooting.
+ Remain current in regulatory expectations and industry practices regarding aseptic practices, process manufacturing technologies, investigations, change control, and CAPA.
+ Be proactive in error proofing and PHP (Pfizer Human Performance) aiming to prevent errors and events.
+ Be responsible for Training / Coaching of technicians in your area of expertise.
+ Gathers and analyzes historical data from the appropriate sources to identify trends and root-cause of manufacturing deviations. Work in collaboration with Manufacturing, Engineering, Quality and Technical Services to recommend corrective and preventive actions to prevent/eliminate recurrent discrepancies as well as potential deviations.
+ Own and lead events and QAR's pertaining to the particular focus area. Initiation, tracking, trending and management of all manufacturing investigations, corrective and preventive actions (CAPA) and evaluation of CAPA effectiveness in the Aseptic & Packaging Operations Department to ensure compliance with quality and cycle time standards.
+ Become an M1 coach to provide guidance and feedback to operators/supervisors who participate in initiating, providing information, completing and conducting investigations and CAPA analysis. Conduct personnel interviews and system reviews. Act as an unbiased investigator with questions surrounding the specific issue.
+ Responsible for working with Manufacturing and Technical Services in optimizing process parameters of commercial processes to evaluate/implement opportunities for process improvements. Participate, lead and manage Quality Risk Management exercises.
+ Own operations commitments / change controls / CAS / action items within your area of expertise. Initiate and lead Change Control projects to ensure timely implementation of CAPAs/process improvements.
+ Evaluate process/procedure changes as necessary and assure changes are implemented in departmental SOPs/MBRs.
+ Track activities derived from Quality Systems in a systematic and effective way to assure timely closure.
+ Provide day to day operations support.
+ Lead Audit Preparation and audit support for your area.
+ Support the operating unit in preventing Events and QARs to enable timely disposition.
+ Provide operations support for projects in your area of expertise.
+ Own documents within your area of expertise. Lead revisions to these documents as required.
+ Feed into the preparation of the APQR (Annual Product Quality Report) as required.
+ Act as the point of contact for introduction of procedure and document changes. Review procedural revisions prior to implementation, prepare and deliver training for new documents and revision training and re-training.
+ Fluent Spanish and English (both oral and written) are required.
+ Ability to write clear and solid technical documents is also a key requirement.
+ Self-starter, able to work autonomously, team player, with strong interpersonal and coaching skills. Proven record of problem solving, decision-making skills and application of improvement tools (M1-six sigma).
+ Demonstrated ability to interact effectively with all levels of the organization -both locally and in the network. Works comfortably and interchangeably on the manufacturing floor and in lab and office environments.
+ Able to adapt and respond positively to a variety of situations and people in order to meet constantly changing conditions and priorities under tight time frames.
EDUCATION & EXPERIENCE:
+ Bachelor's Degree in Pharmacy or Biology preferred. Other Life Sciences or Engineering degrees will be considered.
+ At least five years of experience in production environment (manufacturing, technical services, microbiology laboratory or quality assurance) gained in different pharmaceutical companies/sites.
+ Deep knowledge of Good Manufacturing Practices and other applicable regulatory requirements.
+ Advanced user of QTS and PDOCS (Pfizer corporative system)
+ Working knowledge of Quality tools and statistical software (MiniTab)
+ Six-sigma Green Belt Certification is valuable.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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