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Senior Associate, Quality Compliance

7+ years
Not Disclosed
10 Nov. 28, 2024
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Batch Certification Reviewer (Quality Assurance)
Company: Sun Pharmaceuticals
Location: Not specified (assumed to be based at manufacturing or production facility)


Job Summary

The Batch Certification Reviewer will play a key role in ensuring compliance with Good Manufacturing Practices (GMP) and regulatory standards by reviewing and certifying batch records, packaging records, laboratory data, certificates of analysis, and supporting documentation related to manufacturing processes. This includes ensuring compliance with regulatory requirements and performing a supporting role during regulatory, corporate, and internal audits. The position ensures the quality, safety, and effectiveness of products throughout their lifecycle, from manufacturing to distribution.


Key Responsibilities

  • Batch Certification: Review of batch records, packaging records, QC lab records, certificates of analysis/compliance, and related documentation for compliance with GMP, ALCOA++ principles, and regulatory standards.
  • Deviation Investigations: Lead the review of planned and unplanned deviations, including Out of Specification (OOS) and Out of Trend (OOT) investigations, ensuring proper conclusions and Corrective and Preventive Actions (CAPA).
  • Cleaning Validation: Review cleaning validation documents such as plans, protocols, and reports to ensure they meet regulatory standards.
  • Quality Risk Analysis: Support risk analysis efforts, such as FMEA, for manufacturing processes and equipment cleaning, ensuring appropriate risk mitigation strategies.
  • Compliance and Audits: Participate in regulatory audits, inspections, and provide follow-up on any findings from agencies like the FDA, EMA, etc. Ensure FDA Readiness for the facility and assist with mock inspections to prepare the site for audits.
  • Continued Process Verification (CPV): Review and assess CPV reports and Annual Cleaning Reviews to maintain regulatory compliance.
  • Regulatory Support: Assist with regulatory submissions, ensuring product, process, and equipment compliance to standards.
  • SOP Compliance: Ensure adherence to Standard Operating Procedures (SOPs), assist with the development of new procedures, and identify gaps in existing practices.
  • Additional Tasks: Perform other duties as required, including document reviews, supporting continuous improvements, and ensuring staff adherence to company policies.

Physical and Work Environment

  • Physical Requirements: Ability to lift up to 10 pounds, navigate through office, lab, and manufacturing environments, and wear applicable personal protective equipment (PPE) such as respirators, goggles, and safety shoes.
  • Work Conditions:
    • Corporate office and manufacturing/production environments.
    • Laboratories and warehouse settings.
    • Field familiarity environments.
  • Travel Estimate: Up to 10% of the time.

Educational and Job Qualifications

  • Education: Minimum Bachelor’s degree required; courses or seminars related to quality assurance or GMPs are an asset.
  • Experience:
    • Minimum of 7 years of experience in the pharmaceutical industry, particularly in Quality Assurance, GMP compliance, and batch certification.
    • Experience working in international, multicultural matrix organizations.
  • Technical Skills:
    • Expertise in MS Word, Excel, PowerPoint, Outlook, TrackWise, Learning Management Systems (LMS), and other quality-related software applications.
    • Familiarity with project management principles, including planning and risk management tools.
  • Language Proficiency: Intermediate English proficiency (CEFR B1+).

Compensation and Benefits

  • Base Salary may vary based on factors such as geographical location and experience.
  • Participation in the Annual Performance Bonus Plan.
  • Eligible for comprehensive benefits, including:
    • Medical, dental, and vision coverage.
    • Life insurance, disability insurance.
    • 401(k) savings plan.
    • Flexible spending accounts and employee assistance programs.
    • Paid vacation and sick time.

Equal Employment Opportunity

Sun Pharmaceuticals provides equal employment opportunities for all employees and applicants, ensuring no discrimination based on race, religion, sex, disability, or other protected statuses.


Notice to Agencies and Search Firmsa

Sun Pharmaceuticals does not accept unsolicited resumes from agencies. Any resumes submitted without a signed search agreement will become the sole property of Sun Pharmaceuticals, and no fees will be paid for such submissions.


How to Apply

Interested candidates should apply directly through the company’s career portal or other relevant channels.

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