Aizant Drug Research Solutions Pvt. Ltd is an integrated drug development solutions provider. Aizant was established by experienced pharmaceutical professionals with global exposure. We are a rapidly growing formulation CDMO and CRO with a diverse portfolio of capabilities partnering with health care companies specializing in new molecular entities (NMEs), generics (ANDA’s) and over the counter (OTC’s) products globally.
We are hiring for Executive- Quality Control in our Organization. Interested candidates with Formulation experience can share their update Cv’s to firstname.lastname@example.org.
Experience: 2 – 5 Years
Qualification: B.Pharmacy / M.Pharmacy / M.Sc (Organic Chemistry) / M.Sc (Analytical Chemistry.
JOB ROLE FOR QUALITY CONTROL:
Collection and chemical analysis of water samples . To sample analysis, review of raw materials and packaging materials. Preparation of Certificate of Analysis (COA) for water samples, raw materials and packaging materials. To analyse and release of In process and Finished products, preparation and Analytical reports for In process, finished products and stability samples. To ensure that the HPLC/ GC Columns are used an maintained properly as per GLP .Experience in HPLC GC Dissolution apparatus, OOT and OOS will be added advantage .
JOB ROLE FOR ANALYTICAL METHOD VALIDATION:
Review of Analytical Method validation, Verification and Method transfer data and preparation of Reports. Review of Method development reports, Test methods. Review of API DMF. Preparation of Method validation and Transfer protocols. Handling of regulatory queries
Deputy Manager / Manager – Quality Assurance
Roles and Responsibilities:
- Preparation, training and review of departmental SOP’s and guidelines.
- Monitoring of quality notifications, CAPA, OOS, OOT, change controls, incidents and effectiveness.
- To coordinate the external audits by sponsors/clients.
- Review of raw materials, Packaging materials & finished product specifications and standard test procedures(STP).
- Review and approval of stability compilation & certificate of analysis of Drug product.
- review of specifications and standard test procedures.
- Issue ,control and archival of documents.
- To support and coordinate the issuance of documents sought by sponsor/client.
- Support to automation for implementation of API software (UMS/DMS/TMS/QMS)
- Participation during the execution of qualification of automation(Software-IQ/OQ/PQ)
- Preparation and review of qualification protocols and reports of software (IQ/OQ/PQ).
- Monitoring and review of Document management system(DMS),Training Management system(TMS) activities and its compliance in API software.
- Support/Participation to resolve the errors in API software.
Desired Candidate Profile:
Looking for Immediate joiners & who have worked with pharmaceutical companies.
- Experience: 8 – 10 Years
- Qualification: M.Pharm/ M.Sc
Candidates who have lost their jobs in this pandemic situation will be preferred first.