Sr. Specialist, Quality Assurance Documentation

3 months ago

Columbus, United States Hikma Pharmaceuticals PLC Full time
Job Title: Sr. Specialist, QA Documentation

Location: Columbus, OH

Job Type: Full time

Req ID: 7161

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 750 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 33 manufacturing plants, 9 R&D centers, and 9,100+ 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 Sr. Specialist, QA Documentation to join our team. In this role, you will be responsible for ensuring annual compliance, supporting filing readiness and providing operations support in adherence to internal and external timelines. Providing support for the QA Documentation Supervisor and/or Manager by reviewing/approving documentation, revising/updating templates, WIs and SOPs, providing audit support and continuous improvement projects. Presenting improvements and new processes within cross functional teams to ensure quality and compliance to cGMPs, internal, external and international requirements. This includes the areas of document generation (e.g. Specifications, Stability Protocols, SOPs), or document approval (e.g. Master Manufacturing Formula Cards, Master Packaging Specification, Labelling, MES) and/or Records Retention (e.g. archival, retrieval, destruction).

Key Responsibilities:
  • Reviews and approves master documents which have been revised/created as a result of changes to labeling, materials, manufacturing and packaging processes. Ensures documentation alignment with current SOPs, work instructions, and regulatory filings.
  • Reviewing and approving one-time use documents which have been created as a result of or for the evaluation of changes to labeling, materials, manufacturing and packaging processes. Ensures documentation alignment with current SOPs, work instructions, evaluation protocol and filing requirements.
  • Support filing projects to include all Technical Service projects, continuous improvement projects and R&D projects. May include drafting of necessary documentation to support internal and external timelines.
  • Able to act on behalf of Supervisor/Manager as necessary. This may include meeting attendance, communication with external customers and internal customers, review/approval of documentation and/or drafting of necessary documentation to support internal and external timelines.
  • Update templates, forms and training documentation in adherence to WIs and SOPs, as necessary.
  • Review and approve master documents which have been revised/created as a result of changes to labelling, materials, manufacturing and packaging processes. Master documents updates may be applicable to specifications, analytical procedures, formula cards, master packaging specifications, master design specifications (MES), etc. for continuous improvement or updates to current compendia (USP, EP, etc.). Ensures documentation alignment with current SOPs, WIs, and regulatory filings.
  • Review and support a holistic change control process to ensure adherence to GxP regulations and risk mitigation.
  • Review and Approval of ASRs, ASTRs, SC&Ps, APRs and COAs in accordance with SOPs and WIs.
  • Support timely retrieval of records for audit purposes.
  • Drive adherence and process improvements with regards to master documentation for alignment to standard conventions, regulatory guidance's and best industry practices.
  • The Sr Specialist will approve and oversee a variety of change management disciplines which include regulatory documents and compliance strategies. The Sr Specialist should evaluate all possible scenarios and provide guidance on appropriate actions to be initiated or implemented.
  • Write various document classes (e.g. annual stability reports (ASRs), stability commitment and protocols (SC&Ps), testing specifications, annual statistical trending reviews (ASTRs), certificate of analysis (COAs), annual product reviews (APRs), Master Formula Cards (MFCs), Master Packaging Specification (MPSs) and others as defined) to support the release and on-going regulatory and supply chain commitments consistent with standard operating procedures and department procedures.
  • Support timely retrieval of records for audit purposes.
  • Assimilate and evaluate information regarding historical product performance, operational processes, procedures and regulatory requirements to complete appropriate product risk assessments.
  • May lead Risk Assessment Team activities to ensure risks are assessed and escalated appropriately.
SKILLS
  • Proficient computer skills in Microsoft applications.
  • SAP, Trackwise, and a document management system.
  • Various tasks may benefit from Labware or MES experience.
  • Change management experience to ensure proper guidance and leading of changes across multiple disciplines.
  • Knowledge of stability requirements to ensure proper ongoing evaluation is occurring to meet regulatory commitments (USP, EP, etc.).
  • Mentoring or training of peers or coworkers in previous roles
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:

Education:
  • Minimum: Bachelor's degree or minimum of 6 years combination of quality, production, engineering and/or laboratory experience. Laboratory experience is desirable.
  • Preferred: Bachelor's degree (Chemistry, Biology or Engineering related)
Experience:
  • Minimum: 5 years' experience working for a manufacturing company
  • Preferred: 6+ years'combination of quality, production, engineering and/or laboratory experience with demonstrated accomplishments in effectively implementing cGMP requirements. Minimum of 2 years of MES system change management experience. Laboratory experience.
What We Offer*:
  • Annual performance bonus, commission, and share potential
  • Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay. Hikma will match 100% of the first 6% of eligible pay that you contribute
  • A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date). Additional days granted upon reaching work milestone anniversaries
  • 3 personal days (prorated based on hire date)
  • 11 company paid holidays
  • Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
  • Employee discount program
  • Wellbeing rewards program
  • Safety and Quality is a top organizational priority
  • Career advancement and growth opportunities
  • Tuition reimbursement
  • Paid maternity and parental leave


*Eligibility requirements apply to some benefits and depend on the job classification, role, and length of employment. Benefits are subject to change as well as specific plan or program terms.

Equal Opportunity Employer:

Hikma Pharmaceuticals USA Inc. is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other characteristics protected by law.

Location:

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