Company Overview
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. Our capabilities include Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, commercial supply of APIs and finished dosage forms, as well as specialized services such as development and manufacture of highly potent APIs and antibody drug conjugates.
Position
QA Document Controller
Job Description
Document Controller - assist in day-to-day document control support service.
Responsibilities
* Issuing controlled copies of GMP documentation.
* Logging and tracking of documents through QA department.
* Provide Document Control input including mastering of documentation, issuing documentation to operative departments, scanning and archiving completed documentation.
* Participate in quality-related investigations and assist in developing and approving effective CAPA to resolve production, audit and customer-related issues.
* Supply controlled documents for use in audits to support production and other support functions as required.
* Be involved in the preparation for customer and regulatory audits and inspections.
* Provide document control support for the introduction of new products ensuring all GMP documents are appropriate and all requirements are met.
* Assist in the management of document transfer to off-site archive facility.
Required Competencies
* Attention to detail.
* Good communication skills both verbal and written.
* Good organisational skills.
* Ability to work effectively individually and as part of a team.
* Ability to analyze data and information and make considered decisions.
* Ability to identify root causes of problems and determine appropriate solutions.
* Ability to prioritize workload, follow instructions accurately and escalated issues as appropriate.
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