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Quality Control – Manager.

  • 15 Oct 2019
  • Palghar
  • As per Industry Standards
  • 5 to 7 yrs

Job Criteria:

SECTOR: Healthcare
INDUSTRY: Pharmaceuticals, Biopharmaceuticals, Bulk Drugs
FUNCTION: Bio Tech/R&D/Scientist
SPECIALIZATION: QA/QC
QUALIFICATION: M. Sc. (Science)
KEY SKILLS: ISO, GMP, FDA, Control Organize and Execute Production functions.
ROLE: Quality Control – Manager.
VACANCIES: 1

Job Summary:

  • Our client, a growing global health care company that manufactures pharmaceuticals and medical devices, is looking to hire a Quality Control Manager.
  • This position is responsible for the timely and accurate completion of required testing of Environmental Monitoring, Clean Utilities, Raw Materials, In-Process and Finished Products are assured with compliance to ISO, GMP and company specifications as well as relevant pharmacopeia compendia.
  • This position is responsible to identify areas for continuous improvement and implementation of industry best practices and drive implementation in the laboratory. The Manager keeps laboratory management informed of all departmental activities and product-related events.
  • This is a great opportunity to join an extremely stable and growing organization with an international presence. This position is a key team member in meeting the company’s strategic plan for continued compliance.

Job Responsibilities:

  • Manages daily activities of Quality Control Environmental Monitoring Analysts and assures that job activity deadlines are met on a timely basis.
  • Assures execution of monitoring and testing programs to assess the quality of raw materials, components, in-process and finished goods, environmental systems/utilities systems and effectiveness of production processes.
  • Ensures that raw materials, components, products, or monitoring results that do not meet specifications or expectations are promptly investigated.
  • Investigates and resolves non-conforming test results by completing thorough Deviation, OOS (Out of Specification) / OOT (Out of Trend), and Laboratory Investigation Reports.
  • Identifies the possible source and corrective action needed to evaluate the impact upon the product.
  • Assures department is equipped with functional, calibrated equipment and necessary supplies.
  • Generates new / revises Standard Operating Procedures for Environmental Monitoring and Microbiology test procedures.
  • Identifies adverse microbial quality trends by preparing and analyzing Environmental Monitoring summary reports.
  • Hires and oversees the training of Quality Control department personnel. Assures that steps are taken to maintain positive personnel morale and development.
  • Mentors and develops new department personnel including training in Standard Operating Procedures and on the Job Training (OJT).
  • Reviews work performed by department staff for accuracy, completeness, and conformance to GDP (Good Documentation Practice) and product specifications.
  • Represents the Quality Control Microbiology department in cross-functional teams and internal/external meetings.
  • Excellent interpersonal and communication (written & verbal) skills.
  • Certification: Approved by FDA for Chemical, Instrumentation. (Preferred)

Job Specifications:

  • Experience: 5+ year’s exp. Well versed with ISO, GMP, Regulatory affairs. (Must)
  • Salary: Not a limiting factor for Experienced and Result-Oriented candidates.
  • Location:
  1. The applicant for Pharmaceutical – Nalagarh, Himachal Pradesh, INDIA.
  2. The applicant for Medical Device – Palghar, Maharashtra, INDIA.

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