Date: 07th September 2019
Time: 9:30 AM to 4:00 PM
Venue :
Therapiva Pvt Ltd
Plot Nos. 9/A,B & 22/A,B,C
Phase III
IDA Jeedimetla
Jeedimetla
Hyderabad
Telangana 500055
Production Chemists
Job Role: Production Chemists
Experience: 3 to 5 yrs
Location: Hyderabad
Qualification: B.Sc/M.Sc
Key Responsibilities:
Responsible for day to day shift activities and report to Executive (or) Shift In charge.
Responsible to maintain Good housekeeping in production block and surrounding areas of the production area.
All documents like batch manufacturing and control records, cleaning records, equipment log books, housekeeping and weighing balance checklists etc to be maintained online.
Manufacturing the drug products as per Batch Production and Control Records (BPCR) and performing process operations as per standard operation procedure.
To check all the labels before batch charging.
Any deviation (or) abnormality observed to be intimated to the executive (or) shift in charge.
Responsible to follow safety instructions given in batch manufacturing and control records.
Responsible to attend cGMP, Safety and other trainings conducted.
Responsible to guide casual helpers to get the work in safe manner.
Candidates should have regulatory audit exposure, Good communication and Documentation skills
QA
Job Role: QA Chemists / Assistant Managers
Experience: 5 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: QC Chemists / Assistant Managers
Experience: 3 to 5 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
Production Chemists
Job Role: Production Chemists
Experience: 3 to 5 yrs
Location: Hyderabad
Qualification: B.Sc/M.Sc
Key Responsibilities:
Responsible for day to day shift activities and report to Executive (or) Shift In charge.
Responsible to maintain Good housekeeping in production block and surrounding areas of the production area.
All documents like batch manufacturing and control records, cleaning records, equipment log books, housekeeping and weighing balance checklists etc to be maintained online.
Manufacturing the drug products as per Batch Production and Control Records (BPCR) and performing process operations as per standard operation procedure.
To check all the labels before batch charging.
Any deviation (or) abnormality observed to be intimated to the executive (or) shift in charge.
Responsible to follow safety instructions given in batch manufacturing and control records.
Responsible to attend cGMP, Safety and other trainings conducted.
Responsible to guide casual helpers to get the work in safe manner.
Candidates should have regulatory audit exposure, Good communication and Documentation skills
QA
Job Role: QA Chemists / Assistant Managers
Experience: 5 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: QC Chemists / Assistant Managers
Experience: 3 to 5 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 7 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.
Interested candidates can send their updated resume to muralikbv@therapiva.net or hr@therapiva.net.
Job Role: Research Associate / Scientist
Experience: 3 to 7 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.
Interested candidates can send their updated resume to muralikbv@therapiva.net or hr@therapiva.net.
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