SQUARE GROUP Job Circular 2022
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Published on: 07 Nov, 2022
Application Deadline: 17 Nov, 2022
Vacancy: N/A
Description
Executive, Compliance / Analytical Assurance
Job Status | : | Full Time |
Work Station | : | Kaliakoir Plant, Gazipur |
- Job Descriptions for Compliance:
- Ensuring proper Data Integrity (DI) related issues
- Conducting & Managing Self-inspection/ Internal Audit
- Managing & Ensuring proper documentation for Regulatory / External Audit and Compliance
- Handling & Reviewing of ANDA submission related documents, Compendia and Guidelines updates
- Identifying the gaps and non-conformances in GMP areas/ activities and to take CAPA
- Handling and Review of investigation reports (Deviation, QIR, OOS, OOT, Complaints, etc.)
- Preparing SOP, Training Modules and Presentation on Guidelines, Compendia or Articles and conduction of training
Job Descriptions for Analytical Assurance:
- Reviewing the Protocols and Reports related to Analytical Method Validation/ Verification and Transfer
- Reviewing and verifying the Raw Data and Meta Data related to testing of Raw Materials and Finished Products
- Reviewing the Specifications and Test Methods
- Reviewing and verifying the Working Standard, Chemical Reference Substance, Column and Instruments Calibration related documents and data
- Handling Compendia, Guidelines updates, laboratory QMS
- Establishing In-house systems and procedures to ensure cGLP practices & regulatory requirements for analytical activities & Participating in troubleshooting (related to testing and instruments)
Pre-requisite to apply:
- M. Pharm / B. Pharm (Professional) / MS in Chemistry / Applied Chemistry / Biochemistry & Molecular Biology / MS in Microbiology (From reputed Universities)
- Minimum 2 years’ of relevant experience is mandatory
- Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills
- Strong personal & professional ethical values are essential for the position
- Capable to work in a team and in shifting environment
- Within 33 years of age
Salary Range | : | Attractive remuneration package will be offered |
Only short-listed candidates will be called for further selection process. Hard copy of CV will not be entertained.
SQUARE NEVER ASKS FOR MONEY FROM ANY CANDIDATE AT ANY PHASE OF RECRUITMENT
SQUARE STRONGLY DISCOURAGES SMOKERS TO APPLY
Applicants meeting the requirements of the position are requested to apply through the following link
Apply Now
Associate Scientist, Analytical Research & Development / Technical Services
Job Status | : | Full Time |
Work Station | : | Kaliakoir Plant, Gazipur |
- Job Description for Analytical Research & Development:
- Performing analytical method development for both compendia & non-compendia method
- Preparing and review of method validation protocols and reports
- Conducting analytical method validation/ verification activities
- Carrying out analytical method transfer
- Developing and validating test methods for cleaning validation
- Generating and reviewing laboratory investigation reports
- Conducting review of analytical test data
- Preparing specifications and methods
- Performing regulatory query reply & method equivalency study
Job Description for Technical Services:
- Preparing process validation / experimental batch protocol and reports with statistical data evaluation as per requirement
- Executing manufacturing process validation and re-validation activities owing to manufacturing process improvement, new source of RM / PM (as applicable) development / validation, batch scale-up or scale- down, equipment change etc.
- Participating as a member of Technical Service team in technical investigation to identify the actual route cause of non-compliance and its impact on product quality and patients through risk assessment
- Designing and executing the experiments through challenge study to optimize manufacturing process and validate the formulation and process variables in large scale facilities considering SUPAC guidance
- Executing protocol based study for troubleshooting of existing products, as per recommendation from QMS / or as assigned by the supervisor, with clearly defined project goals – coordinating with cross functional team
Pre-requisite to apply:
- M. Pharm / B. Pharm (Professional) / M. Sc in Chemistry/Applied Chemistry/Biochemistry & Molecular Biology (From Reputed Universities)
- Minimum 2 years of related experience is mandatory
- Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills
- Within 32 years of age
Salary Range | : | Attractive remuneration package will be offered |
Only short-listed candidates will be called for further selection process. Hard copy of CV will not be entertained.
SQUARE NEVER ASKS FOR MONEY FROM ANY CANDIDATE AT ANY PHASE OF RECRUITMENT
SQUARE STRONGLY DISCOURAGES SMOKERS TO APPLY
Applicants meeting the requirements of the position are requested to apply through the following link
Apply Now
Executive, Regulatory Affairs / Production (Sterile manufacturing)
Job Status | : | Full Time |
Work Station | : | Kaliakoir Plant, Gazipur |
- Job Description for Regulatory Affairs:
- Prepare CTD (Common Technical Documents) /ACTD (ASEAN Common Technical Documents) and dossiers for export markets
- Provide updated regulatory information to respective concerns and follow up the implementation
- Review and prepare technical documents associated with CTD / ACTD preparation
- Respond to different queries raised by different regulatory authority associated with dossier evaluation or facility inspection
- Prepare Annexure/Recipes and arrange Drug Testing Laboratories (DTL) samples as per requirement
- Check the newly developed artwork with annexure for both local & export markets
- Maintain liaison with different departments & provide feedback regarding inclusion materials for new products
Job Description for Production (Sterile manufacturing)
- Monitor and ensure the manufacturing process as per planning, guidelines & Standard Operating Procedure (SOP) to ensure in-time production
- Ensure cGMP compliance in all production activities
- Prepare Batch Manufacturing Records (BMR), Batch Packaging Records (BPR) and other documents
- Participate in validation activity
- Supervise & guide the Operators, Helpers and other Production Workers
- M. Pharm / B. Pharm (Professional) (From reputed Universities)
- Minimum 2 years’ relevant experience is mandatory
- Candidate must possess excellent planning & execution skills as well as strong quantitative & qualitative analytical skills
- Within 32 years of age
Salary Range | : | Attractive remuneration package will be offered |
Only short-listed candidates will be called for further selection process. Hard copy of CV will not be entertained.
SQUARE NEVER ASKS FOR MONEY FROM ANY CANDIDATE AT ANY PHASE OF RECRUITMENT
SQUARE STRONGLY DISCOURAGES SMOKERS TO APPLY
Applicants meeting the requirements of the position are requested to apply through the following link