Assistant Manager
1 week ago
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 Power Point.
Previous experience with software related to handling of documents and LIMS.
If interested kindly share your updated cv to
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