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Pfizer Algete is the global supplier of Pfizer’s Haemophilia franchise, including two biological recombinant products to treat Haemophilia A and Haemophilia B. In addition, the site manufactures other 3 products, two of them small-molecule products.
The site performs aseptic filling and lyophilization of vials, QC release & stability testing, kits secondary packaging and direct distribution worldwide under cold chain (2º-8ºC).
The site distributes to over 70 markets including FDA, EMEA and Japan managing over 240 SKUs. The site has approximately 275 PGS employees.
ROLE DESCRIPTION:
You 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 Assessment) 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. You 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).
RESPONSIBILITIES:
- 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.
- Gather and analyze 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 foryour 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.
- Support IMEx in Packaging and Aseptic Operations units, as part of the PCT (Process Centric Team) and giving support as process specialists.
SKILLS:
- Ability to write clear and solid technical documents is a key requirement.
- Demonstrated ability to interact effectively with all levels of the organization, both locally and in the network. Works comfortably and interchangeably on the
