Quality control chemist

placeCarmona calendar_month 

Job Description

Posted on 15 April 2025
  • Coordinates, motivates and monitors the proper functioning of the Quality Control Section.
  • Responsible for the compliance of the quality management of raw materials, in-process and finished products testing to the established Standard Operating Procedures (SOP) and Testing Procedures.
  • Develops & monitors programs/systems/ test procedures to control the quality check and verification of all items under physical & chemical analysis in the most cost-effective and efficient manner.
  • Evaluates measurement and analysis of data & results of all conducted testing on materials, bulk products, in-process goods and finished products prior to its approval and releasing for production use.
  • Ensures the manufacturing and distribution of only Quality products as defined by the company’s specification and requirements indicated in the official monograph or compendia and/or by the individual customer/client.
  • Conducts investigation for any identified non-conformity related to the evaluated results eventually, provide corrective action appropriate to the case.
  • Conducts researches and related studies on new developments pertinent to Quality Control activities.
  • Participates in qualification assessment for the laboratory instruments on its Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) in coordination with the Engineering & Maintenance Department (EMD).
  • Provides technical assistance to the Laboratory Analyst/s whenever problems occur in the analyses being conducted.
  • Facilitates the conduct of the physical-chemical analyses of the Concurrent Stability Studies Program for our Finished Product and report to the Product Development; related results that need to be address in comparison with the Accelerated Stability Studies conducted by the Product Development Team.
  • Maintain cost containment program of the company by maximizing skills and proper control of supplies, e.g. chemical reagents, glass wares and other laboratory supplies.
  • Assists/ supports in the conduct of internal workshops/seminars/lectures on GMP & GLP and other technical-related topics to QMD Personnel.
  • Closely coordinates with the Quality Assurance Supervisor for any quality related issues pertinent to materials and method of analysis and in the performance management of the entire Quality Management functions.
  • Ensures supplier’s management through evaluation of chemical reagents, laboratory equipment & gadgets and reference books & materials used in the performance of quality controlling of product & laboratory services to our valued clients.
  • Performs other function as that may be assigned from time to time.
Qualifications/Requirements
  • Preferably a graduate of B.S. Chemistry, B. S. Chemical Engineer, B.S. Pharmacy; Industrial Pharmacy or any other science-related courses.
  • A professional board license would be an advantage.

Work location

CARMONA, CAVITE

Remarks

Job Scope:

  1. Investigation and identifying the right root cause
  2. Provide analytical and technical skills to maintain company quality services and products
  3. Manages and supervise quality control laboratory activities
  4. Supervision and leading staff
  5. Ensure robust testing procedures and outputs and identifying mistakes or non-conformity issues.

Duties & Responsibilities:

Develops procedures by understanding customer requirements in order to have an effective quality control.
Ensure material and product specifications are in-place for supplier and monitoring compliances.
Collaborated with the Quality Assurance personnel for the implementation of systems, procedures and standards of operation to comply with company standards and local regulations.
Leads the establishments and implementation of procedures for sampling, recording and reporting data.
Supervises and guides all laboratory personnel to ensures quality in the process by which products are manufactured.
Final approver for all GxP documents.
Designated/alternate authorized person for batch release.
Appraises customer’s requirements and ensure satisfaction
Facilitate proactive solutions by collecting and analyzing quality data
Review and ensure all standards and policies are current
Keep records of quality reports, statistical reviews and relevant documentation
Make sure that Out of Specifications are investigated and resolved.
Ensure appropriate actions are taken in case of willful or negligent GMP violations up to and escalating to responsible management for any necessary disciplinary action.
Ensure all legal standards are met to maintain certifications of the laboratory.
Ensure appropriate and timely escalation for quality related matters.
Assess the conclusions of periodic review of process performance, product quality and the Quality Management System.

Monitor effectiveness of quality systems, including performance of GMP and internal audits, metrics monitoring and participation in management reviews.

Lead/Initiates/participates in any process improvements aimed at improving efficiency and savings
Ensure appropriate interface with authorities for any GxP related activities.
Decision on withholding products from distribution if needed, for resolution of quality or compliance issues or mandate market actions, up to and including recommendation for recall of product, following the relevant procedures.
Escalation of any issues due to inadequate resources (personnel, budgetary, etc) to perform quality oversight or duties.

Works collaboratively with other department for completion of investigation through root-cause analysis pertinent to product/customer complaint and other related non-conformities identified within the process in coordination with the department head.

Prepares and submits departmental monthly/quarterly KPI and other report on a timely basis

Lead and representative of Quality control for all regulatory and client audits and prepares necessary aids for external audits.

Facilitate the Quality Council Meetings and is responsible for the oversight of product quality and GMP compliance for all products manufactured or distributed from the site.

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