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Document Control Supervisor

Pfizer


Location:
McPherson, KS 67460
Date:
03/15/2018
2018-03-152018-04-27
Pfizer
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Job Details

Generation and issuance of plant documentation, including Standard Operating Procedures (SOPs), Training Course Plans (TCPs), monographs, Specification Sheets, and shipper label artwork. Plant level distribution of corporate documents. Document structures are constructed to ensure all applicable documents are issued for specific revisions and/or versions. Information is input to ensure the correct information is inserted into documents prior to generation and issuance. The position reviews the generated documents for critical information prior to releasing them to functional areas for use.Generation and issuance of plant documentation, including Standard Operating Procedures (SOPs), Training Course Plans (TCPs), monographs, Specification Sheets, and shipper label artwork. Plant level distribution of corporate documents. Document structures are constructed to ensure all applicable documents are issued for specific revisions and/or versions. Information is input to ensure the correct information is inserted into documents prior to generation and issuance. The position reviews the generated documents for critical information prior to releasing them to functional areas for use.



Accountable for: Ensuring all plant changes to documentation are executed appropriately and effectively according to Plant, Corporate and Regulatory requirements.



Responsible for: Direct training and supervision of documentation personnel, Edit, control and distribution of all SOPs, TCPs, Monographs, Specification Sheets, Data Sheets and Batch Records for the plant operations.



Process owner for Documentation process and responsible for process enhancements



Oversees the review and approval of plant documentation that apply to product, procedures, processes, equipment, facility changes, art work, labeling and all affected systems that undergo changes.



Ensure plant documents are executed appropriately by identifying and applying the appropriate sequence of required deliverables and are implemented in a systematic way to assure effective and timely closure



Oversees the evaluation of process/procedure changes as necessary and assure document changes are implemented according to corporate, site and regulatory guidance. .



Act as primary document control representative for major plant and corporate projects, track/trend and report site change management metrics to site Management staff identifying/elevating documents potentially interfering with critical path metrics.



Additional responsibilities as defined by Quality Management.







Requires bachelor's degree in scientific field or equivalent GMP biopharmaceutical experience. Requires a minimum previous 2 years in a leadership position. The preferred candidate will have a minimum 5 years with direct involvement overseeing documentation activities in a regulated industry..







Strong oral, written, communication, presentation and interpersonal skills. Capable of interfacing with multiple levels of people within the organization, including Corporate management, third party customers, and plant personnel. Superior problem solving skills required. Must be capable of organizing data from multiple sources, extracting key information to report metrics. Experience with word-processing, spreadsheet and presentation software (e.g. MS Word, Excel, Access and Paradox) Experience using data analysis computer tools and statistical analysis is preferred. Experience working in a cross-functional, matrix environment







This position will be responsible for ensuring all plant documentation changes are executed appropriately and effectively according to Plant, Corporate and Regulatory requirements. Independent action and sound decision-making are essential for success in the position as decisions can impact regulatory filings, product release and compliance with GMP.







**EEO & Employment Eligibility**



Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.







**Sunshine Act**



Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.







**Other Job Details:**







+ **Last Date to Apply for Job: 4/10/2018**



+ **Eligible for Relocation Package - Yes**







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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