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Document Control Supervisor
2 weeks ago
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
In your role, you have the all-important task of preparation and review of required documentation, such as Good Manufacturing Practices, Good Laboratory Practices (GLP), Good Clinical Practices (GCP) manuals. You will be relied on to prepare procedure manuals, quality control manuals, engineering documents, manufacturing instructions and change authorizations in accordance with company policy and government regulations. Your skills will help you implement related documentation systems, propose change control processes and coordinate the review of procedures and forms. You will also provide input on quality control procedures and R&D documentation.
As a Team leader, you will be involved in managing work teams in a division, along with technical and financial resources of the team. You will coach your direct reports on day-to-day activities. and be relied on to solve complex problems within your area of expertise.
It is your dedication and hard work that will make it possible for customers and patients to receive the medicines they need, when they need them.
How You Will Achieve It- Manage multiple projects/ongoing work activities (timelines, work plans, deliverables) of moderate complexity.- Support project objectives through document design/creation/revision, document review and training course development.- Work with internal teams to design, create and implement documents (using human performance principles or other relevant tools) that are user friendly and compliant.- Develop, maintain and ensure the site document management system including procedures, guidelines, templates, numbering, filing compliance to Pfizer Quality Standards (PQS) and ICH guidelines.- Ensure documentations are updated to the latest version and issued to shop floor.- Ensure control of changes / updates / proper filing/archival and easy retrieval in the document management system.- Control issuance and reconciliation of critical GMP forms used by various departments on site and the use is meeting the data integrity requirements.- Ensure the site document retention schedule align with the Pfizer guidelines and meeting the regulatory requirements.- Provide cataloging of the existing archival system, allocate archival space and issue proper retention schedule label code for department owners, monitor and track the space of archival room.- Arrange, manage and coordinate the physical destruction of documents with department owners and third-party contractors.- Supervise and/or review outputs of colleagues, contractors or supporting staff, as required, for project support activities.
**Qualifications**:
Must-Have- Bachelor’s Degree and 6+ years of experience.- 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 in Technical writing, creating electronic documentation and using electronic document management systems.- Good knowledge on ALCOA
Nice-to-Have- Master’s degree and relevant pharmaceutical experience.- People Management experience.- Strong oral, written, communication, presentation and interpersonal skills.- Experience in traditional and modern training methods (mentoring, coaching, on-the-job, in classroom training, e-learning, workshops, simulations etc.) preferred.- Experience in developing high-quality training materials (including those with pictures, animations, videos and simulations).
Work Location Assignment: Flexible
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control
LI-PFE
