Shantha Biologics is hiring experienced professionals for Quality Assurance, IPQA/IPQC, and IPQM positions in Hyderabad.
The openings are suitable for professionals with experience in biopharmaceutical manufacturing, validation, quality operations, and microbiology.
Candidates with B.Pharm, M.Pharm, M.Sc, and relevant Life Sciences qualifications can apply for the respective positions.
The available roles require 5–13 years of relevant experience, depending on the position.
Company Overview: Shantha Biologics
Shantha Biologics has announced openings for experienced professionals across QA Validation, IPQA/IPQC, and IPQM functions. The positions are based at Muppiredipally, Hyderabad.
These roles involve activities related to qualification and validation, in-process quality checks, batch record review, microbiology records, environmental monitoring, contamination investigations, CAPA, and support for quality assurance activities.
Shantha Biologics QA Validation: Assistant Manager
Key Responsibilities
- Execute and review qualification/validation activities (IQ/OQ/PQ) for equipment, utilities, filling lines, isolators, and AV systems.
- Manage validation lifecycle activities, including risk assessments, deviations, CAPAs, change controls, and validation documentation.
- Support process, cleaning, and computerized system validation and act as validation SME during audits.
Eligibility & Qualifications
- M.Pharm
- M.Sc. in Relevant Life Sciences Discipline
- Relevant experience in equipment, utility, CSV, filling line, and isolator qualification
- Strong understanding of cGMP, Annex 1, and regulatory inspections (USFDA/EMA)
Experience
9–13 years of experience
Candidates should have relevant experience in qualification and validation activities within pharmaceutical or biopharmaceutical manufacturing environments.
Shantha Biologics IPQA/IPQC: Sr. Executive
Key Responsibilities
- Line Clearance & In-Process Checks
- Review BMRs, BPRs and Analytical Testing Records
- Handling Deviations, OOS and OOT investigations, change controls & investigations
- Conduct shop-floor training & provide audit support
Eligibility & Qualifications
- B.Pharm
- M.Pharm
- M.Sc. in Related Discipline
Experience
5–8 years of experience in IPQA/IPQC within Biopharmaceutical Manufacturing
Candidates should have practical experience in IPQA/IPQC activities and quality operations within a biopharmaceutical manufacturing environment.
Shantha Biologics IPQM: Sr. Executive
Key Responsibilities
- Review Microbiology Records & BET Results
- Verify Environmental & Utility Monitoring
- Lead OOS/OOT & Contamination Investigations with CAPA
- Support Sterility Assurance & Aseptic Monitoring
Eligibility & Qualifications
- B.Pharm
- M.Pharm
- M.Sc. in Microbiology
- M.Sc. in Biotechnology
- M.Sc. in Chemistry
- Related Field
Experience
5–8 years of experience in Biopharmaceutical Manufacturing
Candidates should have relevant experience in microbiology, environmental monitoring, contamination investigations, sterility assurance, and aseptic monitoring activities.
Location & Salary
Location: Muppiredipally, Hyderabad
Salary: Not mentioned in the recruitment notification.
How to Apply for Shantha Biologics Jobs
Interested and eligible candidates can apply by sending their updated resume to the email address provided in the recruitment notification.
Apply Email: nra@shanthabiologics.com
Candidates should mention the position applied for clearly in their application and ensure that their resume highlights relevant experience in QA, validation, IPQA/IPQC, IPQM, microbiology, or biopharmaceutical manufacturing, as applicable.
Shantha Biologics QA & Quality Jobs: Job Summary
| Company | Shantha Biologics |
| Vacancies | Assistant Manager QA Validation; Sr. Executive IPQA / IPQC; Sr. Executive IPQM |
| Required Education | M.Pharm; M.Sc. in Relevant Life Sciences; B.Pharm; M.Sc. in Related Discipline; M.Sc. in Microbiology; M.Sc. in Biotechnology; M.Sc. in Chemistry |
| Experience | Assistant Manager QA Validation: 9–13 years; Sr. Executive IPQA/IPQC: 5–8 years; Sr. Executive IPQM: 5–8 years |