Technical Service Specialist

Role Overview

• Identifies and addresses both current and potential issues as they become evident (via Continued Process Verification) through monthly trend analyses of Critical Process Parameters (CPP) and Critical Quality Attributes (CQA) Data from In-Progress Product Quality Review (iPQR); and Long-term and Accelerated Stability Study Data from Stability Reports.
• Performs Validation Activities for New Products (NPDs), and Existing Products as warranted by CPV (for Process Improvements);
  
  

Performs Equipment Qualification: Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Equipment Cleaning Validation (ECV), and Computer Systems Validation (CSV), for newly acquired Production Equipment and Testing Instruments.

• Acts as Project Leader or participates as an active member/contributor in Product Improvement Initiatives and/or Special Projects (i.e. Alternate Supplier Development) within and outside the Plant.
• Reads pharmaceutical literature and attends trainings (local, foreign and online) to keep abreast of the advances in pharmaceutical sciences (dosage format and processing technologies) and to gain in-depth knowledge of active drug and excipients used in all existing products (physical/ chemical profile, stability, incompatibilities, etc.).
• Assists in training new/transferred employees in performing tasks related to RM dispensing.
  
  

Serves as role-model on proper decorum and positive behavioral influence in observing company rules and regulations.

• Practices Operational Excellence (OE) in the shop floor.
  
  

Qualifications

• Bachelor’s degree (4-year course) in Pharmacy, Chemistry, or Engineering
• 3–6 years of relevant experience in pharmaceutical manufacturing or related fields
• Solid knowledge of:
• GMP
• Basic Pharmaceutical Technology
• Product and Process Validation
• Latest advances in pharmaceutical manufacturing
• Strong analytical skills, including statistical analysis and trend evaluation
• Capable of working under minimal supervision

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