Date: 21st September 2019
Time: 9:30 AM to 3:00 PM
Venue :
Swagath Grand Suchitra Circle
Suchitra Road, Medchal Rd,
Secunderabad,
Telangana 500055
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Job Role: Executive / Sr. Executive (QMS / AQA / Documentation)
Experience: 3 to 9 years
Location: Hyderabad
Qualification: M.Sc.(Chemistry)
Key Responsibilities :
Review of BPCRs in line with technical package received for various projects from R&D centre.
Review and approval of executed BPCRs received from manufacturing department related to various projects.
Organizing and imparting trainings for various training programs.
Checking online operations in concerned departments for ensuring GMP compliance.
Handling and review of deviations and change controls related to concerned departments.
Handling of customer complaints.
Handling of OOS.
Reviewing and approval of concerned department SOPs.
Preparation, Review and approval of quality assurance SOPs.
Preparation, Review and approval of Purified water system protocol, data and report.
Online monitoring of purified water system for compliance.
Review and approval of AHU protocols, data and report.
Preparation, Reviewing and approval of cleaning validation protocols.
Review and approval of process validation protocols and reports.
Reviewing and approval of equipment qualification protocols and reports.
Handling of internal audits.
Identification of various procedures related to concerned departments for effective quality system implementation.
Vendor qualification management.
Facilitate during customer / regulatory audits by coordinating with Head-QA.
Release of API / Intermediate.
Candidates should have regulatory audit exposure, Good communication and Documentation skills
QC
Job Role: Executive / Sr. Executive (Analyst / Wet Chemistry/ QMS / Investigation)
Experience: 3 to 9 years
Location: Hyderabad
Qualification: M.Sc.(Chemistry)
Key Responsibilities :
Monitoring of work allocation and previous day output review,
Ensure current and relevant specifications, testing procedures and standard operating procedures are available in the laboratory to carry out the testing,
To ensure required Reference standards, Columns, working standards, Microbiological media, etc. are available for testing,
Release and Rejection of Raw materials, In process, Finished products and Packaging materials.
Expertise in analyzed & handle finished products, in process samples, packing material, stability samples,
Responsible for completion of activities such as OOS, OOT, CAPA, Calibration and maintenance of all Q.C related instruments,
Analytical support to all Process Validation activities, QC Documentation Control (Preparation, review & updating of QC SOPs ), standard testing procedure and specification,
Knowledge of method development, impurity profiling, method validation technology transfer, validation, establishing specifications for new launch products
Competent in establishing QC lab as per cGMP/ cGLP requirement,
Strong exposure in regulatory / customer audit expectations, audit compliance report and response to regulatory agencies queries
Co-ordination with internal customer departments, along with Lab support team which covers Calibrations of all QC instruments, Internal /External Audit & Compliance.
Preparation & maintenance of working standards, Primary standards, Reference standards, Formation & Stability cell & handling of all stability study related activities, Instrument / Equipment Qualification activities.
Candidates should have regulatory audit exposure, Good communication and Documentation skills
API Process R&D
Job Role: Research Associate / Scientist
Experience: 3 to 9 years
Location: Hyderabad
Qualification: MSc/ Phd (Organic Chemistry)
Key Responsibilities:
Literature search for novel route scooting and development for APIs & Intermediates.
Develop economically viable process for existing molecules (TLCM).
Trouble shooting of the problems occurred in plant .
cGMP documents preparation.
Positive and confident individual with strong work ethics.
Candidates should have regulatory audit exposure.
Team player and good communications skills.
API - Analytical R&D
Job Role: Research Associate / Scientist / Sr.Scientist
Experience: 2 to 8 years
Location: Hyderabad
Qualification: M.Sc (Analytical Chemistry)
Key Responsibilities:
Candidate should be working in reputed API Manufacturer having 1-6 yrs of experience.
Having the Knowledge of Analytical method development and method validations by HPLC &GC.
Having the Knowledge of Data integrity and Audit trails compliance handling with Empower 3.0 Software.
Having the knowledge of Cleaning validations, Technology transfer activity, with good documentation skills.
Positive and confident individual with strong work ethics.
Team player and good communications skills.
Interested candidates can send their updated resume to gousebs@therapiva.net or hr@therapiva.net.
Regards,
HR Team
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