Production Documentation Specialist

Responsibilities
Support Audits and Inspection
Archiving documents/files and maintaining archiving database
SOP review phase 1 and 2
SOP processing in EDMS
Supporting in EDMS: Proof sheets; reports; validation master plans; position papers, specifications; drawings
Printing: Batch records; packaging records; logbooks
Others: Managing ‘Initials’ process

Job requirements
Develop the technical expertise, personal skills and interpersonal skills needed to perform duties in line with Site expectations.
Support an effective internal communications structure with relevant departments.
Contribute to the performance of work (both in terms of volume and quality) as well as the lead time of the documentation department.
Documentation:
• Ensure that SOPs are developed according to cGXP guidelines and Global requirements.
• Manage the documents in a robust EDMS and ensure proper archiving for non EDMS documents.
• Ensure that current standard operating procedures are accurate, current with regulatory guidance and aligned with cGXPs.
Collaboration:
• Maintains relationships with other functions.
• Seeks to provide solutions, not just identify problems.
Proactive Orientation:
• Recognises when changes in product, process or regulations will require changes in tasks and plans accordingly
Results Orientation:
• Can get things done.
• Identifies and escalates potential obstacles to achieving (team) goals.
• Accepts accountability for own decisions and behaviours.
Delegation:
• Identifies gaps in the number of resources and in capability of the department and works with departmental management to develop solutions.

Qualifications and experience:
MBO
Knowledge and experience in working with Microsoft Office and Microsoft Word
(Desirable – MBO+ with 1-2 years of experience in a quality position in the pharmaceutical industry).
Experience with pharmaceutical processes, techniques and cGXP.

Knowledge/ Technical competencies:
• Ability to collaborate with internal team during inspection and to provide timely and thorough support.
• Ability to stay current with and apply in daily activities a strong working knowledge of cGXPs/ regulatory guidance’s to ensure full compliance.
• Ability to ’translate’ the local SOPs to day-to-day activities in the review and approval of documents.
• Knowledge of relevant regulatory guidance’s (within the scope of responsibilities).
• Ability to promote continuous process improvement/ efficiency.
• Support in analyzing and assessing processes and implement improvements resulting in compliant, effective and efficient operations for quality at the site.