Alembic Pharmaceuticals Walk In Interview 2022 Alembic Pharmaceuticals Notification full details below. Interested and eligible candidates can attend interview on scheduled time and venue. Alembic Pharmaceuticals Limited dates back to over 100 years. Established in 1907 with an objective to develop and revolutionize the Pharmaceutical and Drug industry in the Indian subcontinent, Alembic Pharmaceuticals Limited today is one of the leading pharmaceutical companies in India.
- Department :- QA/QC/Microbiology (API)/Injectable IPQA
- Post Name: Executive / Sr. Executive
- Qualification: M.Sc. / M. Pharm
- Experienced: 02 – 7 years
Job Description: Greeting from Alembic Pharmaceuticals !!!!
Important Details :
- Location: Vadodara (Gujarat)
- Post of date:25/01/2023
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to Face
- Interview Rounds of Interview: HR
Roles and Responsibilities:
- To review the Qualification activity and related documents.
- To prepare and review of Qualification Protocol and report of New Equipment.
- To Review and Preparation of Risk Assessment and FRA.
- To Review and preparation of Impact Assessment.
- To Review the Changes Control , Deviation and CAPA and its effectiveness.
- Exposure of Qualification / Validation of utilities.
- Knowledge of current regulatory guidance.
- Perform root cause analysis for investigations pertaining to deviations related to
qualification / validation activities.
- Exposure of HVAC, isolator, autoclave, vessels, vial washing machine, lyophilizer, dynamic
- Exposure of Qualification / validation of utilities such as water system, pure steam system, compressed air system, nitrogen gas system.
- M.Sc. / M. Pharm
- Having experience of 3 to 5 years in Validation & Vendor Qualification.
- Having worked in Formulation OSD & Injectable.
Interested & eligible candidates can share their updated CV on “firstname.lastname@example.org“
Roles and Responsibilities
1. Analysis of In-process, Intermediates, Raw material, Packing material, Finished products, Stability study, Hold time study, Process validation, Cleaning samples, Vendor development and any analysis allocated by team leader and release with proper documentation..
2. Ensuring analysis is performed compliance to GLP.
3. Ensuring analysis raw data is documented on-line.
4. Initiation, Completion and filing of Daily analysis reports.
5. Ensuring any abnormal results, incidents, deviations, discrepancies are reported immediately to the reporting Section Head.
6. Ensuring all relevant log entries are made for every activity wherever applicable.
7. Supervise compliance to all cGMP, GxP or any other regulatory requirements including EHS requirements.
8. Report any quality concerns or suggestions for improvements to Department Head.
9. Execute and supervise all tasks and activities as per the applicable SOPs and company policy.
10. To maintain the safety norms while working in lab. (e.g. Wear goggles, PPE, Disposal of sample/media as per procedure etc).
11. Ensuring analysis is performed as per valid procedures and by using calibrated instruments / Standards.
12. Ensuring self-discipline with respect to wearing aprons, attendance and personnel hygiene and inter relations.
13. To perform Labware LIMS related activities.
14. Any other assignment given by the Section Head or Department Head.
Having experience of 2 to 5 years in QC (API plant)
Interested and eligible candidates can share your CV on “email@example.com“
Roles and Responsibilities
- To handle daily Microbiology operations.
- To handle ELMS and LIMS systems.
- Department training coordinator for new joiners.
- To conduct monthly trainings as per annual training plan.
- Complete management of area qualification and periodic HVAC validation for microbiology
- Co-ordination, scheduling, and evaluation of routine activities.
- Monitoring Stability Schedule and Plan as per Stability Schedule of product.
- Follow up with maintenance team for breakdown related issues for microbiology laboratory,
PM and calibration activities.
- Review, verification, and maintenance of logbooks, records, and raw data.
- Inventory management like reagents, media, accessories, and consumables.
- Allotment and approval of sample in LIMS software.
- Successfully faced MHRA audit without any major, minor or critical observation.
- Executed validation in microbiology as per regulatory requirement.
M.Sc. in Microbiology
Having experience of 2 to 5 years of experience in API plant.
Interested and eligible candidates share your CV on “firstname.lastname@example.org“
Roles and Responsibilities
- To perform line clearance at each stage of manufacturing and packing.
- To monitor dispensing of Raw materials and packaging materials.
- Sampling of in-process materials, finished products, Reserve samples, validation samples and stability samples.
- Responsible to release the finished product.
- Responsible for rejection of the In-process /Semi finished /finished product.
- Monitoring of personnel movement & clean room behavior in process area.
- To ensure Incoming materials quality & verification of dispensed materials for adequacy.
- To participate in the investigation of deviation and to participate in Implementation, Effectiveness verification of CAPA.
- Planning, execution and review of various validation protocols and documents to meet project deliverables of aseptic manufacturing facility.
- Ensure cGMP compliance & following standard in process checks at shop floor in manufacturing/packing activities as per batch record.
- Initiation and review of change control forms related to Quality Assurance department and review of change controls of other related cross functional departments.
- Initiation and review of Deviation, CAPA and Investigation.
- Verification of handling of online rejects.
- To participate in execution and compilation of process validation and cleaning validation activities.
- Review of master records, Validation protocols, Qualification Protocols, BMRs & BPRs.
- Review and maintenance of IPQA related documents.
- To coordinate with concern departments for execution of aseptic process simulation (Media Fill) and review media fill documents.
- Collection of swab samples.
- Preparation and review of SOPs/protocol/reports in Documentum/DCS.
- Preparation and review of risk assessment and cGMP impact assessment.
- Involve in visual inspection qualification programme for AQL and production visual inspector qualification.
- Review of specification, Preparation of qualification protocol, execution of qualification.
- Review and execution of Trial, scale up batches and related documents.
- Responsible to carry out other assignments delegated by the Head of the Department from time to time based on qualification, experience and training
Desired Candidate Profile
Experience: 4 to 8 years of relevant experience in IPQA
Interested & relevant candidates can share their updated CV at “email@example.com” with the subject line as “Injectable-IPQA”.