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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: QA Batch Certification Specialist
Company: Sun Pharmaceuticals


About Us

Sun Pharmaceuticals is a leading global provider of high-quality pharmaceutical products. Our commitment to quality and compliance ensures that we meet regulatory standards while delivering innovative treatments that improve patient outcomes.


Job Description

The QA Batch Certification Specialist is responsible for ensuring compliance with regulatory and quality standards related to manufacturing, packaging, and laboratory processes. This role supports batch certification for U.S. commercial distribution, ensures adherence to cGMPs, and participates in regulatory audits and inspections.


Key Responsibilities

Batch Certification and Documentation

  • Conduct certification reviews for manufacturing batch records, packaging records, QC lab records, and related documentation.
  • Verify compliance with SOPs, laboratory applications, and ALCOA++ principles.
  • Support the review of cleaning validation documents, including plans, protocols, and reports.

Investigations and Quality Risk Management

  • Conduct reviews of site deviations, including OOS/OOT investigations.
  • Ensure adequacy of conclusions, corrective actions, and preventive measures.
  • Assist in quality risk analysis for manufacturing processes and equipment cleaning using FMEA methodologies.

Regulatory Compliance and Audits

  • Ensure compliance with FDA readiness plans, regulatory audits, and inspections.
  • Participate in mock inspections and gap assessments to prepare the facility for audits.
  • Address findings from regulatory bodies and internal/external inspections.

Continuous Improvement

  • Identify compliance gaps and recommend changes for quality improvements.
  • Support adherence to SOPs and ensure procedures reflect current practices.

Qualifications

Education and Experience

  • Bachelor’s degree (minimum requirement).
  • 7+ years of experience in the pharmaceutical industry.
  • Experience in international, multicultural matrix organizations.

Technical Skills

  • Proficiency in GMPs, including good documentation practices.
  • Expertise in software applications (MS Office Suite, TrackWise, LMS, Acrobat Reader).
  • Knowledge of project management principles and tools.

Communication and Soft Skills

  • Strong interpersonal, organizational, and communication skills.
  • Ability to work effectively in multicultural teams and matrix organizations.
  • Proficiency in English (Intermediate-B1+ or higher).

Physical Requirements

  • Ability to lift up to 10 pounds and navigate office, lab, and manufacturing environments.
  • Ability to wear personal protective equipment, including respirators and safety gear.

Additional Requirements

  • Familiarity with cleaning lifecycle reports, CPV, and annual cleaning reviews.
  • Understanding of compliance with product, process, and release procedures.

Work Environment

  • Office, laboratory, manufacturing, and warehouse settings.
  • Travel up to 10% may be required.

Compensation and Benefits

  • Competitive salary with eligibility for annual performance bonuses.
  • Comprehensive benefits package, including medical, dental, vision, life insurance, 401(k), flexible spending accounts, and employee assistance programs.
  • Paid time off, including vacation and sick leave.

Equal Opportunity Employment

Sun Pharmaceuticals provides equal employment opportunities and prohibits discrimination based on race, gender, age, disability, or other legally protected categories.

Note: Sun does not accept unsolicited resumes from third-party agencies or search firms.


Join us in shaping a healthier future with innovative pharmaceutical solutions. Apply now!