Name of Company / Institution: Interchemex Laboratories Inc.
Address: 900 Palace St., BF International, Las Pinas City 1740
Company Brief Description:
INTERCHEMEX LABORATORIES, INC. is a toll manufacturing and distribution of pharmaceutical products.
Interchemex engaged in the business of developing, manufacturing, marketing and distributing generic and private-label pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores.
Interchemex also assists drug traders every step of the way starting from securing the necessary regulatory requirements of BFAD, to production and quality monitoring, to delivery right to every clients’ stockroom.
Job Title: QC Analyst
Duties and Responsibilities
1. Performs sampling and conducts physical and chemical analyses of raw materials, in-process products, finished goods and packaging materials in accordance with approved procedures and established test methods.
1.1 Prepares reagents and standard solutions needed in laboratory analyses.
1.2 Orders and maintains adequate levels of chemicals and supplies for QC laboratory.
1.3 Recommends approval or rejection of samples tested based on results of analyses.
1.4 Communicates status of test results to QC Head for review, approval or final disposition.
2. Accurately documents test results and prepares laboratory reports where required. Reviews accuracy of laboratory data entries.
• Maintains laboratory records, logbooks, and reports in compliance with Good Documentation Practices and Good Manufacturing Practices.
3. Prepares Standard Operating Procedures (SOPs) and Work Instructions (WI’s) applicable to the operation of QC Laboratory.
• Reviews SOP’s, WI’s and other lab documents. Recommends appropriate
changes where needed.
4. Performs stability tests of products in accordance with established procedure and records findings. Reports to QC Head any deviations from specifications noted during product evaluation.
5. Assists in the investigation of the root cause of deviation (Out-of-Specification) and in formulating corrective and preventive actions.
6. Conducts and monitors the working condition and calibration of laboratory instruments. Ensures that instruments / equipment are maintained in good repair and under calibrated status. Maintains equipment maintenance and calibration records.
• Recommends repair and re-calibration of instruments as needed.
7. Ensures that retention samples of starting materials (RM/PM), bulk products and finished goods are maintained in accordance with established procedure.
8. Conducts in-process inspection of manufacturing operations. Communicates to QC Head and Production management any deviations noted for outright correction.
• Ensures accurate documentation of inspection findings.
• Reviews Batch Production Record during in-process operations to ensure the timely and accurate accomplishment of the document.
• Ensures the implementation of GMP in manufacturing areas.
9. Initiates continual improvement of the Department’s work practices and procedures.
10. Assists in providing technical support to Production.
11. Provides data for Annual Product Quality Reviews, Validations and Risk Assessment in areas of responsibility.
12. Collaborates with Production in conducting process validation and equipment cleaning and sanitation validation.
13. Trains other analysts to perform laboratory procedures and assays.
14. Participate in internal assessments and audits as required.
15. Ensures that laboratory facilities, systems and procedures conform to PIC/S-GMP, 5S standards and safety requirements.
The Quality Control Analyst should be a licensed Chemist or Chemical Technician. Preferably has experience in a pharmaceutical manufacturing company and working knowledge of Good Laboratory Practices (GLP), Laboratory Safety, Good Manufacturing Practices (GMP), and PIC/S (Pharmaceutical Inspection Co-Operation Scheme).
Salary Range (PHP): 20,000 – 25,000
Contact Person / Details:
Jayson G. Bernaldez – QC Department Head
INTERCHEMEX LABORATORIES, INC.
Address: 900 Palace Street, B.F. International, Las Piñas City, Philippines 1740
Tel. Nos.: 826-7922, 829-7605 & 788-0581