QC Compliance Specialist

Sun Pharmaceutical Industries-posted 3 months ago
$75,500 - $83,000/Yr
Full-time • Mid Level
New Brunswick, NJ
5,001-10,000 employees
Chemical Manufacturing
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Under limited supervision, manages laboratory compliance activities for assigned functions and projects. Investigates method performance, reliability and improvement issues, and evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, Method Validation/Transfer Protocols and Reports, SOP's accordingly to company's standards and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and update the related documents to implement the changes and ensure the compliance.

  • Writes technical documents such as methods, specifications, method validation protocols and reports, method transfer protocols and reports based on corporate policies and SOP's, compendial, ICH and FDA regulatory guidance.
  • Ensures that the integrity and accuracy of all laboratory documents are maintained; must assess overall document compliance with protocols, SOPs, company policies, and applicable regulations.
  • Evaluates compendial documents, and reviews procedures for laboratory compliance.
  • Evaluate Sun global documents (GQS and GSOP) against site specific procedures and update the site procedure accordingly.
  • Reviews analytical data for accuracy, completeness and compliance to cGMPs and established laboratory documentation standards.
  • Generates change requests required for analytical documents, and routes documents for review and approval. Maintains hard copies and electronic file of technical documents.
  • Timely provide the QC documents required for CBE, PAS and ANDA submission to RA.
  • Collaborates with colleagues and external partners to achieve individual and department goals.
  • Ensure compliance with cGMP's, DEA regulations and site operating procedures under the direction of QC Management.
  • Ensure Lab Event/Out-of-Specification and Out-of-Trend investigations are properly conducted and closed on a timely fashion.
  • Ensure continuous laboratory compliance by adopting best industry practice and complying with procedure requirements.
  • Minimum BS or equivalent degree in Chemistry or related discipline.
  • Good computer skills, and competence with Microsoft Office (Word, Excel, PowerPoint) and Access.
  • Must have an understanding of FDA guidelines, ICH guidance and DEA regulations.
  • Must have LIMS and SAP knowledge.
  • Must be familiar with proper cGMP practices for analytical laboratories and working knowledge of basic laboratory instrumental analysis and wet chemistry skills.
  • Must have cGMP compliance knowledge and experience.
  • Demonstrated strong communication: verbal, written and presentation skills.
  • A self-starter with a hands-on approach and a can-do attitude.
  • Excellent project management and problem solving skills.
  • The requirement for English language proficiency for this job role is Intermediate-B1+ (comparable to Global CEFR Independent B1) level based on the Common European Framework of Reference for Languages (CEFR).
  • Minimum of four (3) years of experience in the pharmaceutical industry preferred.
  • Medical, dental and vision coverage
  • Life insurance
  • Disability insurance
  • 401(k) savings plan
  • Flexible spending accounts
  • Employee assistance program
  • Paid time off benefits, including vacation time and sick time
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