Senior Executive, Quality Control

Job Summary

To Support QC lab for Procurement, Inward and Issuance of standards, Impurities, Chemicals, Solvents, Columns and Other miscellaneous items for analysis. Indent in SAP, Generation of IH house standards, Cordinate with GTA for inventory procurement and shipment.

Job Responsibilities

• Coordination with respect to SOP harmonization; harmonization in specifications, test methods and formats as per Apotex Inc. and LIMS requirement.
• Raising Indent for required material, follow-ups and co-ordinate with purchase department, supplier, manufacturer and vendor.
• Co-ordinate for receipt and approval of Invoice.
• Co-ordinate for shipment of samples to Apotex.
• Shipment tracking and co-ordinate with warehouse to clear the shipment at customs.
• Retrieve stored data from the data logger and return the reusable data loggers to sending group along with data logger cover letter.
• Ensuring all the requiremnts to qualify secondary standards.
• Inventory stock checking for chemicals and reagents in LIMS on monthly basis.
• Co-ordinate with vendor and GTA for procurement of standards, impurities and placebo.
• Issuance of inventories to the analysts for analysis and responsible for maintenance of inventory management.
• Vial filling of standards for analysis of daily usage and monthly usage.

• Raising work order to maintenance department if any problem persist in the laboratory maintenance like lights, temperature / humidity, door access, flooring, painting, water leakage, washroom cleanliness etc,.
• Responsible for USP/EP/BP catalog review as per schedule.
• Performing the daily monitoring and recording of temperature and humidity of laboratory.
• Submission or sending of standards to other Apotex sites.
• Inventory for standards, impurities, placebo and system suitability solutions, analytical standards, chemicals, solvents and columns.

• Responsible for Implementation and Control of Quality systems in the laboratory.
• Works in a safe manner  collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education
  • A minimum M.Sc/B.Pharm or any equivalent degree.
• Knowledge, Skills and Abilities
  • Should be proficient in MS office tools.
  • Should have competent verbal & written communication skills.
  • Experience of working on online modules / software would be an added advantage.
  • Hands on experience in finished product testing, stability sample testing (Solid Oral Dosage form) and completion within stipulated timeline by following GLP.
  • Knowledge on preparation of various documents like SOP’s, Formats, Protocols, Reports, analytical data etc.
  • Should have well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities.
• Experience
  • Minimum 5 to 9 years of experience in GMP regulated Pharmaceutical Industry