Operational Specialist

7 days ago

Hyderabad Secunderabad Telangana, India beBeeInvestigation Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title:

Premise and Responsibility Associate Manager
  • The aim of this position is to provide collaboration and management with process experts and the multifunctional operations teams in Steriles/Large Molecules platform to manage deviations effectively.
  • The individual will actively participate in investigations of Deviations/Complaints/OOXs by interacting with Cross Functional Teams (CFT) and implementation of Corrective and Preventive Actions (CAPA), Effectiveness Check (EC), Risk assessment, and Quality Management.

Key Responsibilities:

  • Participate in conducting quality risk management framework assessments.
  • Utilize structured RCA methodologies like impact assessment, Fish bone diagram, 5 whys, Timeline & Process mapping for investigating deviations.
  • Experienced handling Investigations and Deviations related to Process (Upstream / Downstream), Product & Equipment.
  • Understanding core manufacturing unit operations such as sampling, monitoring, and continuous process support.
  • Work within GxP environment and adhere to procedural requirements for HA audits.
  • Offer technical and scientific expertise to address process-specific matters ensuring compliance with cGMPs, SOPs, and relevant guidelines.
  • Audit preparation for area of responsibility -Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt
  • Certification in investigation handling – Root cause analysis (RCA) preferred.

Essential Requirements:

  • Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS or equivalent experience.
  • Minimum 5 years of experience in MS&T, Quality Assurance, Regulatory or in the manufacturing of pharmaceutical drug substance or drug products in Sterile/Large Molecules platform/facility.
  • Minimum of 5 years of pharmaceutical process validation and cleaning validation.
  • Familiarity with basic statistical evaluations using Minitab or other statistical analysis tools.
  • Proficient knowledge on deviation handling, incident investigations, root cause analysis, and CAPA management.
  • Knowledge of risk assessment and risk management programs.
  • Familiarity with regulatory guidance on validation, product filing, and post-approval changes.
  • Basic knowledge of statistical analysis, results interpretation, and usage of statistical tools.
  • Good communication, presentation, and interpersonal skills.

Desirable Requirements:

  • Bachelors degree in pharmacy, Pharmaceutical Technology, Chemical Engineering, Biomedical engineering, Biotechnology, Chemistry, or equivalent science streams. Desirable MSc/MS or equivalent experience.

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