Sterile Injectables QA Compliance Specialist

2 weeks ago

Davangere, Karnataka, India beBeeCompliance Full time US$ 1,50,000 - US$ 2,50,000
Quality Assurance Specialist

We are seeking a Quality Assurance Compliance Specialist to join our team. This is an exciting opportunity for a highly motivated and detail-oriented individual to play a key role in ensuring the quality of our products.

Job Description:

The Quality Assurance Compliance Specialist will be responsible for preparing and reviewing QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes. This includes reviewing, approving, and trending Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.

Key Responsibilities:

  • Prepare and review QMS-related documents, including SOPs, work instructions, and templates for validation, qualification, and compliance processes.
  • Review, approve, and trend Change Control (CC) records, assessing potential impact on validation, process performance, and regulatory compliance.
  • Handle deviations by reviewing deviation reports, assessing adequacy of root cause analysis, recommending corrective/preventive actions, and ensuring timely closure in compliance with procedural requirements.
  • Review, approve, and trend deviations for recurrence patterns and systemic issues; prepare periodic deviation trend analysis reports for management.
  • Review and approve market complaint investigations, ensuring thorough root cause identification, adequacy of corrective/preventive actions, and compliance with regulatory timelines.
  • Review and approve investigation reports for OOS (Out-of-Specification), OOT (Out-of-Trend), and any critical quality incidents, ensuring accuracy, completeness, and regulatory compliance.
  • Conduct remote compliance checks of controlled documents to ensure adherence to cGMP, US FDA, and other applicable regulatory requirements.
  • Manage vendor quality activities remotely, including review of vendor qualification/approval documentation, participation in vendor audits (virtual or on-site as required), and review of vendor audit reports.
  • Handle vendor quality notifications and change notifications by reviewing the impact on processes, products, and regulatory compliance, and coordinating required actions with relevant departments.
  • Support and participate in virtual internal and external audits, providing requested documentation, clarifications, and evidence.
  • Monitor and trend QMS performance metrics (e.g., CC closure rates, deviation frequency, CAPA on-time completion, vendor performance metrics) and prepare quarterly quality performance reports for management.

Required Skills and Qualifications:

  • In-depth knowledge of sterile injectable manufacturing processes and aseptic techniques.
  • Expertise in validation methodologies and regulatory guidelines (US FDA, cGMP etc.).
  • Strong analytical and problem-solving skills.
  • Effective communication and documentation skills.
  • Ability to manage cross-functional teams and prioritize tasks.
  • Proficiency in QMS tools and software.

Education and Qualifications:

  • Bachelor's/Master's degree in Pharmacy, Biotechnology, Microbiology, or related field.

Benefits: Competitive salary and benefits package.

Others: Opportunity to work with a talented team and contribute to the success of our organization.

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