Quality Assurance Manager

2 weeks ago

nalgonda district, India SinterX Pharma Private Limited Full time

Position Title: QA Chemist (Team Member)

Company Name: Sinterx Pharma Private Limited

Location: Valigonda, Choutuppal.

Description:

The QA Chemist with 5 to 8 years of experience is responsible for ensuring that all API intermediate manufacturing operations comply with established quality standards, GMP requirements, and regulatory guidelines. This role involves reviewing and approving GMP documentation, overseeing batch records, managing deviations and CAPA, conducting internal audits, and ensuring continuous compliance across the production lifecycle. The QA Chemist will collaborate with cross-functional teams including Production, QC, and R&D to maintain quality excellence and support regulatory inspections.

Educational Background:

  • Bachelor’s or Master’s Degree in Chemistry, Pharmaceutical Sciences, or Life Sciences

Work Experience:

  • 5 to 8 years of experience in Quality Assurance within the API or API Intermediate manufacturing industry
  • Hands-on experience in preparing and reviewing GMP documentation such as BMRs, BPRs, and SOPs
  • Strong understanding of regulatory guidelines (GMP, ICH, FDA, etc.) and data integrity practices

Key Responsibilities:

  • Review and approve batch manufacturing records (BMRs), batch packaging records (BPRs), change controls, deviations, and CAPAs.
  • Ensure compliance with cGMP, ICH, FDA, and other applicable regulatory guidelines across all operations.
  • Perform in-process quality checks, line clearance, and review of raw material and intermediate usage.
  • Prepare and Manage documentation systems including SOPs, validation protocols, and logbooks, ensuring adherence to ALCOA+ principles.
  • Support internal audits, vendor audits, and regulatory inspections by preparing and reviewing necessary documentation.
  • Review and approve analytical and stability reports from QC to ensure accuracy and compliance.
  • Monitor and support training programs to ensure employees follow quality procedures and standards.
  • Lead or support quality risk assessments and provide QA input during technology transfer, scale-up, and commercial manufacturing.
  • Actively participate in investigation of deviations, OOS/OOT results, and ensure effective CAPA closure.
  • Collaborate with Production, QC, AR&D, and Regulatory Affairs to maintain a culture of quality and continuous improvement.

Required Skills:

  • Strong knowledge of GMP regulations, ICH guidelines, and data integrity practices
  • Proficiency in reviewing and managing GMP documentation (BMR, BPR, SOPs, validation protocols)
  • Strong analytical, problem-solving, and decision-making abilities
  • Experience in handling deviations, CAPA, and risk assessments
  • Familiarity with QMS software, LIMS, or other quality management systems (preferred)
  • Excellent organizational and reporting skills

Key Attributes:

  • High attention to detail and commitment to compliance
  • Strong communication and interpersonal skills
  • Ability to multitask and manage priorities in a dynamic environment
  • Proactive approach to continuous improvement and regulatory readiness

Interested candidates can share their profiles at Hr@sinterxpharma.co

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