Aizant Drug Research Solutions Pvt. Ltd Released Job Openings On 27-11-2021.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 add exponential value to our clients R&D programs at every stage of drug development right from the discovery of the molecule to commercialization and subsequent life cycle management. We are the vital link between the pharmaceutical companies and the healthcare industry.
Vacancy Details:
Aizant Drug Research Solutions Pvt. Ltd Recruiting Candidates with 8-12 years experience for Manager / Sr Manager – Quality Assurance Position.Complete Details for the Manager / Sr Manager – Quality Assurance as follows.
Important Details :
- Location : Hyderabad/Secunderabad
- No of Vacancies:NA
- Details of Salary:Not Disclosed by Recruiter
- Opening date for online Application:27-11-2021
- Mode of application :Online
- How To Apply: Interested candidates can share their updated resume to careers@aizant.com
Job Description/Skills Required
- Ensuring GCP / GLP and SOP compliance.
- Review/Approval of clinical study protocols/bio analytical method SOPs and their associated documents.
- Timely review/approval of study / validation reports (includes clinical/bio analytical/PK & Stats).
- To plan / conduct in-process and retrospective audits at different phases of the study (e.g., Clinical, bio analytical, PK & Statistics and Diagnostics) as applicable.
- To plan / conduct periodic internal audits of other departments.
- Review/approval of audit reports, receiving of the responses and verification & follow-up of the corrective/ preventive actions.
- Issuance of audit certificates.
- Review / investigation of Change control, Deviations, Incidents, Events, Note to Files.
- To monitor and follow up the pending CA/PAs.
- Review of instrument/equipment qualification documents, Calibration records.
- Preparation, Review of QA and other departmental SOPs.
- Training and evaluation of department personnel.
- Coordinate and lead/support during the external audits by sponsor/regulatory authorities.
- Coordinate and prepare to respond to the regulatory queries.
- Any other work assigned by the Department head.
- Person should have good hands on experience in handling the Audits – Clinical for regulated markets.
- Interested candidates can share their updated resume to careers@aizant.com
- Pharma experience is mandatory.
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