Pfizer QC External Support Specialist in Grange Castle, Ireland
Closing Date - 23th August 2018
Quality Control External Support Specialist
Position Reports to:
QC Technical Manager
To provide analytical, quality, reference material and analytical technical transfer expertise to the countries where Pfizer products are supplied to market, for regulatory submissions to those countries, to contract manufacturing sites, contract testing sites, Pfizer sites, board of health laboratories, emerging markets, OMCL test laboratories, COQA and product technical and supply chain teams.
QC Laboratory Operations Lead
QC Technical Manager
QC External Support Specialist
Primary Contact responsible for addressing commercial product (e.g. Enbrel/Prevenar/Trumenba/BioSimilar products) analytical queries from Grange Castle regulatory and Global regulatory teams.
Technical review and critique of analytical sections/normative documents for all new filing applications for established and new products as directed by QCES manager.
Co-ordination and technical review of responses to agency questions on analytical methods.
Provide technical support to all new country launches.
Technical support to OMCL/Board of Health Labs on analytical queries related to Enbrel/Prevenar/Trumenba and other products as directed.
Provide routine analytical and technical support to contract test labs and contract manufacturers. Maintain regular communications with all contract manufacturing/testing sites via monthly/quarterly meetings as deemed necessary per product.
Management of external analytical method transfer projects to rest of world markets/Pfizer sites and/or contract test laboratories.
Management of external analytical method transfer projects to new emerging markets/localisation projects.
Support stability teams as requested (temp excursions, contract sites stability programs, expiry extensions/change control review etc). Act as QCES rep on stability review boards.
Global APQR support for Enbrel/Prevenar/Trumenba as directed by QCES manager.
Management of and support to critical reagents/reference standard supply/inter country shipments to ensure continued supply to all markets, CMO sites and external customers as required.
Support importation testing queries and support for rest of world labs via country affiliates and from packing site (e.g. Pfizer Havant).
Work with all partners associated with the supply of Enbrel /Prevenar/Trumenba as part of End to End processes to ensure continued supply of product to markets.
QC representative/active participant on Analytical Task Force, Tech Team, BLAST, and Product Team meetings as required for each of the products Enbrel/Prevenar/Trumenba and new products as required.
Representative on Biotech Change control review boards (BCRB) for all products to assess impact of all changes presented to QC Grange Castle and follow up on assigned implementation activities.
Grange Castle QCES representative on analytical specification review committees.
Support operations of the Quality Control testing laboratories as requested by QC management.
Support MSAT teams to provide QC assessments/information related to analytical test procedures/data trends/other analytical data as required.
Lead and participate in continuous improvement projects within the QCES team.
Provide support to agency site inspections as required.
Host visits to site from Board of Health Laboratories or other government agencies from ROW in support of future import testing requirements locally or as part of new product submissions.
Record and review all analytical documentation (method transfer/filing sections etc to cGMP standard.
Generation of area KPIs and dashboards as required.
Oversee the generation of area SOPs.
Ensure Biennial review of area documentation is completed.
Incorporate management guidelines and policies.
Implement and adhere to appropriate levels of cGMP within the work area.
Promote safety awareness and the established culture of IIF within the assigned work area.
Adhere to local safety regulations
Report any non-conformances to the QC Manager.
Perform and assist in additional duties as may be directed by QC Manager
Work with customers to ensure planning of all project work/assigned activities to meet agreed timelines.
People / Values People leaders
Demonstrate the GC OWNIT values
Adhere to all HR Policies as appropriate
Personal Development plans focusing on the 70:20:10 guidelines
CI tools/- capability is a key building block for learning & development - Trained and M1 certified.
Proactive engagement with key stakeholders.
Best practices developed and shared with other teams /sites.
Best practices actively sought and copied.
Proactive & effective communication within and across shifts
Experience with technical elements of the analytical method validation and transfer process.
Experience with Lab systems an advantage. (LIMS, CDAS, QTS, PDOCs).
Proven success in proactive project management.
Experience is managing multiple projects and reporting regularly to management and senior management within the organisation.
Proven expertise and technical competence.
Proven ability to communicate problems and required resolution in a positive and proactive manner.
Self-directed, self-motivated with a demonstrated record in project accountability.
Proven knowledge in analytical techniques, analytical instrumentation theory and practice.
Proven ability to recognise problems with equipment, methods, software, procedures and resolve the issues.
Excellent communications skills
Demonstrated capability of dialogue to Senior Management
Demonstrated success in networking across sites/functional teams both internal and external to site.
Some travel may also be required as part of this role.
B.Sc. degree in biological/chemical sciences, business, or other related technical degree or equivalent experience in regulated industry.
4-6 years relevant quality experience as detailed above in the responsibilities section within a QA/QC GMP environment in a Pharma/Biotech company.
Excellent communication and interpersonal skills.
Ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.