- Walk- In at Therapiva Private Limited for Production Chemists / QA / QC
- 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.
- 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.
- 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.
Date: 03rd August 2019
Time: 9:30 AM to 4:00 PM
Venue :
Therapiva Private Limited
Plot # 218 & 219, Phase II,
IDA Pashamylaram,Sangareddy,
Telangana.
Landmark: Beside Biocon Ltd.
Production Chemists
Job Role: Production Chemists
Experience: 1 to 4 yrs
Location: Hyderabad
Qualification: B.Sc/M.Sc
Key Responsibilities:
QA
Job Role: QA Chemists
Experience: 2 to 6 years
Location: Hyderabad
Qualification: M.Sc.(Chemistry)
Key Responsibilities :
Job Role: QC Chemists / Assistant Managers
Experience: 2 to 8 years
Location: Hyderabad
Qualification: M.Sc.(Chemistry)
Key Responsibilities :
Interested candidates can send their updated resume to ranjit.nalbothu@therapiva.net or hr@therapiva.net.
0 Comments