Accuprec Research Labs Pvt Ltd. is FDCA approved, NABL accredited and ISO 9001:2015 certified CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA. Accuprec provides all type of Pharmaceutical testing solutions to its domestic and MNC clients.
Research Associate (ADL/QC)
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 2+ years
Job Description
- Candidate having more than 2-4 years of experience
- Experience of HPLC, GC and other chromatography systems, having knowledge of Validation, calibration.
- Experience in Analytical testing of Analytical Method development/Validation/Verification and analysis by HPLC.
- Instrument Operation, Calibration of HPLC Responsible for preparation of STP, Forms & Formats, and SOP etc.
Assistant Manager (ADL)
Qualification : M.Sc./M.Pharm
Experience (Min. Years) : 8+ years
Job Description
- Candidate having more than 10 years of experience
- Experience in review of HPLC, GC and other chromatography systems (Preferred faced regulatory audit like USFDA / MHRA / TGA)
- Responsible for Preparation and Review of Analytical method development and validation.
- To guide team members for cost effective method development.
- To monitor the execution of R&D samples, stability samples, raw materials and excipients received from contract giver.
- To provide job training and related advance topics as and when it require.
- Responsible for execution and approval of Analytical Instrument Qualification and Calibration.
- Responsible for preparation, review and approval of STP, SOP, Protocol and its reports.
- Responsible to ensure all quality related issues are handling as per respective SOP, investigation to identify root
- Cause or most probable root cause and appropriate CAPA initiate to avoid reoccurrence of the same
- Responsible to maintain and follow GLP and GDP in compliance manner in laboratory.
Research Assistant / Research Associate (GC, GC- MS)
Qualification : M.Sc./M.Pharm
Experience (Min. Years) : 2+ years
Job Description
- Experience in Analytical testing of Analytical Method development/Validation/Verification
- Experience in Bio analytical Method Development/Validation/Verification, Analytical Method Transfer, Method
- Nitrosamine impurity method development, validation and analysis by GC-MS
- Method development for GC-MS/MS Method like SIM, MRM, dMRM, Optimizer Study of chemical characterization, extractable and leachable by GC-MS.
- Instrument Operation, Cleaning and Calibration of GC-MS
- Responsible for preparation of STP, Forms & Formats, GTP, SOP etc.
Research Associate (QA - QMS)
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 2+ years
Job Description
- Review of CCN, impact assessment, approval, follow up for change, compliance and effective implementation.
- Received documents for CCN, deviation closure.
- Review of deviation, impact assessment, approval, follow up for change, compliance and effective implementation.
- Review of Market complaint, compliance and closure
- Review of OOS, compliance and closure.
- Review of Incident with attachments and closure.
- Review of OOS with attachments and closure.
- Review of OOC with attachments and closure.
Research Assistant / Research Associate (GLP-AD/QC)
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 2+ years
Job Description
- To review of Spec/STP/GTP and protocol, sign and compliance
- To review of SOP, index, distribution for QC.AD
- To review and verify INB, LNB and sign with completion of all details.
- To review of status label for all instruments with all details (i.e calibration due date, done date, make, model)
- To review initiated CCF with all details, approval and closure with effective implementation.
- To review of deviation, approval and closure with effective implementation.
- To review of OOS, participate in investigation, root cause analysis, hypothesis and effective closure.
Research Assistant / Research Associate (AQA)
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 2+ years
Job Description
- Responsible for Column performance record verification
- To Review of equipment maintenance format for all instrument daily.
- To review of instrument status label for all instruments.
- To review of calibration certificate for every instruments
- Daily balance verification and monthly calibration.
- Daily review and verification records for all stability chamber.
- Daily review and monitoring of all stability chambers.
- Review of instruments log book for all instruments daily.
Assistant Manager (QC)
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 8+ years
Job Description
- Supervise and lead the team of QC chemists for various wet lab analysis, phytochemical analysis, food testing, stability testing and like.
- Depending upon the requirement, you will have to supervise and lead the team of ADL analysts for Analytical Method Development, Analytical Method Validation, Technology Transfer, Force Degradation study, Preformulation study, Dissolution studies, Query Handling etc.
- Work for increase in output of the company by streamlining sample flow management, appropriate timely testing, verification of COA and followed by report submission using AccuLims.
QA Reviewer
Qualification : M.Sc./ M.Pharm
Experience (Min. Years) : 8+ years
Job Description
- Supervise team of ADL analysts for Analytical Method Development, Analytical Method Validation, Technology Transfer, Force Degradation study, Preformulation study, Dissolution studies, Query Handing and like.
- Supervise team of QC chemists for various wet lab analysis, phytochemical analysis, food testing, and stability testings and like.
- Supervise team of ADL & QC personal for development, implementation and modification of SOP, implementation of QMS as per GLP, FDCA, NABL and USFDA standards, change control and documentation, review of COA and verification of Validation reports, training of staff for QMS, vendor qualification and like.
* Positions Open for Ahmedabad Location
Interested candidates send their resumes on email ID with clearly mentioned the post applied : career@accuprec.in
(Mention your In-Hand Salary, Current CTC, Expected CTC, Notice Period)
Note : Mention Post in Subject Line which you are applied for.
Salary no bar for right candidate.
Last Date : 15th June, 2023
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