Specialist, Document Control (Quality)

Job Title:          Specialist, Document Control

Location:         Columbus, OH

Job Type:          Full time

Req ID:              11148

 

About Us: 

As a developer, manufacturer, and supplier of essential medicines, Hikma Pharmaceuticals USA Inc. and its affiliates’ mission is to bring Better Health. Within Reach. Every Day.® for millions of patients around the world.  We are a trusted, reliable partner and dependable source of over 800 high-quality generic, specialty and branded pharmaceutical products that hospitals, physicians and pharmacists need to treat their patients across North America, the Middle East, North Africa and Europe.  Through our 32 manufacturing plants, eight R&D centers, and 9,500+ employees worldwide, we are always hard at work creating high-quality medicines and making them accessible to the people who need them.

 

Description:

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds.  We are seeking a talented and motivated Specialist, Document Control to join our team.  

In this role, you will be responsible for writing and/or reviewing various document classes to support the release and on-going regulatory and supply chain commitments consistent with standard operating procedures and department procedures:

Document Control Generation

• Annual Stability Reports (ASR)
• CofAs (Certificate of Analysis)
• Stability Commitment and Protocols (SC/P)
• Annual Product Review (APR)
• ASTRs (statistical annual product review)
• Statements (e.g. BSE/TSE, Melamine, etc.)
• Testing Specifications/Analytical Procedures

Document Control Review

• Operations (MFC, MPS, Master Design Specifications (MDS), EBR)
• Labeling (MLS)
• Back up for Issuance of Master Documentation

Records Retention

Audit Support.

 

Key Responsibilities:

Document Generation:

• Responsible for writing/revising and or reviewing ASRs, SC/P, APRs and SAPRs in accordance with standard operating procedures (SOP’s) and departmental procedures (work instructions). 
• Author and/or approve (CofAs) for finished products or raw materials as requested.
• Support updates of specifications/analytical procedures as per internal and external timelines.  Duty is required as part of change control for either continuous improvements to documentation or updates to current compendia (USP, EP, etc.).
• Research, author and/or approve requests for regulatory statements for products or raw materials as requested.
• Drive adherence to process with regards to creation of analytical procedures, specifications, stability protocols/reports, statements and annual product reviews for alignment to standard conventions.

 

Document

• Support the change control review and approval process for operations documentation (MFC, MPS) and the ancillary Master Data requirements.
• Support the change control process for labeling via the GLAMS system and the necessary MLS and guardian systems.
• Ensure the paper change control process for Master Manufacturing Formula Cards, Master Packaging Specifications and applicable technical reports.
• Review, support the change control process which supports the development, implementation and maturation of the Electronic Batch Record Change Control process. Interface with MES team to support quality mindset and input on quality related concerns. 
• Support timely retrieval of records for inspections.
• Other duties as assigned

 

Qualifications:

We value the skills and experiences candidates bring to the table.  While we have listed some qualifications below, we encourage candidates to apply even if they do not meet all of them:

• Bachelor’s degree (Chemistry and/or Engineering and/or Biology) or a minimum of 3 years combination of quality, production, engineering and/or laboratory experience, with demonstrated accomplishments in effectively implementing cGMP req