Posted to MedZilla on 8/18/2019


Takeda Pharmaceuticals

US-GA, Sr Quality Assurance Specialist SR0032755-MZ


 
 

Execution Lead for the Quality System element(s) assigned:

Ensures that the Quality System elements assigned comply with the global process and regulations.

Collaborate and communicate with global function and sister sites to align on goals and best practices.

Leads site continuous improvement initiatives.

Ensures that quality system metrics / trends are reported as established by the site and/or internal Quality System metrics.

Leads ongoing daily departmental activities

Provide training, guidance, and coaching for Quality System staff supporting Quality System element(s) assigned

Assists other departments in understanding the achievement of quality goals in an efficient, accurate, compliant and timely manner.

Participate in DMAIC projects in the role of contributor, coordinator or leader.

Support site audit and inspections (e.g. Internal Audits, FDA and other regulatory body inspections)

Perform compliance related activities (e.g .walkthroughs, local audits and compliance reviews, GMP training)

Coordinate and assist with TrackWise system deviations

Review and approve Insignificant and Significant Change Control records.

Ensure that Management reviews and Product Quality Reviews (PQR) are conducted as required by the relevant procedures.

Coordinates customer complaint response and tracking.

Maintain expertise in quality systems and quality processes

Participate and lead projects within the department as assigned by management

Write, review and approve new or revised procedures.

Participate in internal or external assessments, as required.

Communicates with other managers (cross functional) for process improvements, alignment of quality concepts

Provide training within the department and to other department employees (e.g. NEO,GEMS, Change Control, Compliance, GMP )

Requirements

Understand and able to perform all the primary activities as defined in QAI and QAII jobs

Strong technical writing skills

Sound decision making and problem solving skills

Understanding of manufacturing processes

Understanding of quality systems element

Proficient in utilization of Quality Systems such as TrackWise, VEEVA

Demonstrates solid communication skills (verbal and written) with management and peers and be able to work cross-functionally with other groups.

Must demonstrate effectiveness in supporting continuous improvement and promoting the control and prevention of potential issues

Solid presentation skills are required.

Data analysis skills are required

Qualifications:

Bachelor degree in science, engineering or other technical field.

Five (5) + years related experience

Notice to Employment / Recruitment Agents:

Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.

Equal Employment Opportunity

Shire, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

Reasonable Accommodations

Shire, a wholly-owned subsidiary of Takeda, is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.


Please visit our website at takedajobs.com

 
 


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  considered, please do so. Applications for all positions are subject to each employer's specific requirements.