Quality Control Manager Pharmaceutical Manufacturing Plant

Sungai Petani Kedah RM8000 to 12000

$ 12,000.00 monthly Kuala Muda, Kedah 4 February

CHIS International Technical Resources Sdn. Bhd.

  • Description

    Qualification : Master/ Degree in Chemistry(10-15years’ experience)

    Job Summary:
    1. The position is responsible for Quality Control and Stability Management Quality System at Sun Pharma, Malaysia and is accountable for assuring the supply of high Quality and GMP compliant drug products to Sun Pharma customers and business markets.
    2. Provide training to staff on SOPs, cGLP and cGMP standards.
    Essential Job Functions:
    1. Management of QC operations for receipt, testing and approval/ rejection of all incoming materials, In-process Products and Finished Products.
    2. Ensure analysis of test samples as per approved Standard Test procedure for Raw Materials, Packing Materials, In-Process Samples and Finished Products.
    3. Maintenance of Reference Standards, Working Standards and other standards required in QC.
    4. Compliance to documentation as per SOP on Good Documentation Practices and cGMP Guidance for document taken in Laboratory Control and Management.
    5. To ensure that all analysts are trained on SOP, General procedures and are qualified as applicable.
    6. Ensure that analytical data is reviewed by analyst/reviewer. In case of any Lab Deviation with respect to procedure, it is investigated and documented.
    7. Ensure that testing labs were approved and contracts for analysis available before utilizing services.
    8. Ensure all reference standards, cultures are procured from authorized/Pharmacopoeial distributor and approved vendor wherever applicable.
    9. Responsible as audit team member for internal audit conduct at site.
    10. Should have comprehensive knowledge of OOS/OOT investigations and implementation of CAPA.
    11. Should have comprehensive knowledge of 21CFR Part 11 compliance
    12. To ensure Lab consumables are procured of good standards and are managed with full records of receipt, storage, issuance and disposal.
    13. Ensuring Validated and Standard analytical method are used for analysis.
    14. To ensure calibration for critical testing and measuring instruments.
    15. Identify training needs of employees of QC under direct report.
    16. Review of analytical documentation and approval of certificate of analysis.
    17. Co-ordination for technology transfer products during new product launches.
    18. Pharmacopoeial review of specification and management of document control system at the plant.
    19. Review and approval of Specifications, Sampling instructions, test method and other QC procedures.
    20. Achieving financial/productivity goals, hiring decisions and reviewing employee performance.
    21. To prepare annual budget for Laboratory expenses of Quality Control Laboratory.
    22. To prepare the annual budget for equipments, modifications, under capital investments.
    23. Monitoring project and other expenses of Laboratory in running year and monitoring project and capital investments.
    24. Provide troubleshooting support to analysts in the lab.
    25. Conduct /oversee backup of all computer related software used in Laboratory.
    26. Support best practices in Laboratory in terms of integrity, accuracy and adequacy of the testing and documentation.
    27. Provide leadership and direction to ensure achievement of all Commercial and Exhibit Stability Operations accountabilities at the site.
    28. Review of Stability analysis trend data in order to study impact of increase or decrease in Results on Product Quality.
    29. Ensure compliance for Commercial and Exhibit stability program and related activities to cGMP Standards.
    30. Support Regulatory Operations for submissions, including timely submission of stability data, data retrieval during inspections, and statistical trending of stability data.
    31. Ensure timely testing and release of all test samples (including stability, process validation) as per approved specifications, STP and Customer requirements.
    32. Communicate and oversee outsourced analytical service providers responsible for testing whenever required.

  • Number of vacancies: 1
  • Requirements

  • Minumun level of education: Bachelor´s Degree
  • Years of experience: 13
  • Language(s): English
  • Availability for travel: Yes
  • Availability for change of residence: Yes

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