Pharma Job Openings Latest at Hetero Labs Ltd., Apply On Rasayanika
Job Title: Junior Executive / Executive – QA Injectable
Company: Hetero Labs Ltd.
Location: Hyderabad, Telangana
Experience: 2–4 Years
Educational Qualification: B.Sc / M.Sc / B.Pharm / M.Pharm in any specialization
Salary: As per current CTC and company norms
Interview mode: F2F
Position Overview
We’re seeking a motivated QA professional specializing in injectables to ensure quality compliance across manufacturing operations. You’ll be integral in validation, in-process & final product quality assurance (IPQA/QA), qualification, and maintaining the quality management system (QMS).
Key Responsibilities
- Develop, review, and execute validation protocols (IQ, OQ, PQ) for injectable manufacturing equipment and processes.
- Perform routine and in-process QA/IPQA inspections and sampling to ensure adherence to SOPs and GMP standards.
- Support qualification activities (equipment, utilities, cleaning, computerized systems).
- Ensure compliance with national and international regulatory standards (e.g., DCGI, WHO, USFDA, EMA).
- Monitor and maintain Quality Management System (QMS): manage deviations, CAPAs, change controls, and documentation.
- Conduct internal quality audits and support external regulatory inspections.
- Collaborate with cross-functional teams: Production, QC, Engineering, Microbiology (QA & Microbiology interface), and Regulatory Affairs.
- Participate in risk assessments and product quality reviews for continuous improvement.
- Provide training on quality procedures, GMP, and documentation protocols.
Qualifications & Experience
- BSc / MSc in Life Sciences, BPharm / MPharm.
- 2–4 years of QA experience in injectable dosage forms within a regulated pharmaceutical environment.
- Strong grasp of validation principles (process/equipment/cleaning/computer systems qualification).
- Hands-on experience with IPQA and Quality Assurance functions.
- Proficient in QMS activities: deviation handling, CAPA, change control, SOP management.
- Sound knowledge of GMP regulations and regulatory authority expectations.
- Experience working with QA & Microbiology functions is a plus.
Skills & Competencies
- Excellent understanding of Validation, IPQA, Quality Management Systems (QMS), and Qualification processes.
- Good knowledge of Quality Compliance and Analytical Quality Assurance (AQA).
- Familiarity with GMP requirements and regulatory guidelines.
- Strong documentation, analytical, and troubleshooting abilities.
- Excellent communication skills and ability to collaborate with cross-functional teams.
- Detail-oriented with a problem-solving mindset.
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