Assistant Manager

1 week ago


Hyderabad, Telangana, India Masadir Full time

Dear Professionals.,

Greetings from Masadir

We have urgent job opening for Assistant Manager - QA - Bioassay job in well-established company at Hyderabad location.

JOB DETAILS:

Position: Assistant Manager - QA - Bioassay

Location: Hyderabad, Telangana

Salary : Industry Standards

Qualification: Postgraduate in Biotechnology or Pharmaceutical sciences.

Experience : Proven work experience (8-10 years) in Quality assurance with minimum of 3-5 years in CGMP and managing team.

Job Description:

Job Overview:

Quality Assurance personnel is responsible for implementing Daicel Quality Policy and Quality Management Systems. The day-to-day work includes enforcement of quality standards and routine process checks.

Responsibilities And Duties:

  • Responsible for leading a QA team of Bioassay and provide expertise in bioassays to the team.
  • Ensure the team's training, development, and growth.
  • Review of Bioassay method development and method validation.
  • Ensure effective implementation of Quality Policy & Objectives.
  • Review and supervise the drafting of standard operating procedures (SOPs)
  • Responsible for Compliance monitoring, and implementations of DCTI's Quality Management System, Policies and procedures in applicable areas.
  • Review of Equipment Qualification data and calibration data.
  • To handle critical quality systems like incidents, deviations, change control, CAPA, training, OOS. Participate in investigations and review of incidents, deviations, OOC, OOS, OOT and CAPA.
  • To ensure document control and data integrity in applicable areas.
  • To handle and support during the audits conducted by Regulatory bodies, statutory bodies and customers.
  • Responsible for ensuring archival and retention of all the documents and records as per the procedure.

Qualifications:

  • Good knowledge of relevant regulatory standards and understanding of FDA, EU, ICH guidelines and regulations.
  • Ability to troubleshoot problems and communicate effectively in a scientifically sound manner.
  • Effectively collaborate across functional lines in a matrix environment.
  • Good communication skills, both verbal and written.
  • Good knowledge of Microsoft office tools like MS word, MS excel and PowerPoint.
  • Previous experience with software related to handling of documents and LIMS.

If interested kindly share your updated cv to


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