Medical Quality Affairs Roles at Alkem Laboratories | Apply Now
Looking for a Medical Affairs Job in the pharmaceutical industry? Alkem Careers is hiring professionals for a role focused on Pharmacovigilance (PV), Clinical Trial (CT) Quality Assurance, audits, regulatory compliance, and quality management systems. This opportunity is suitable for candidates with a Master’s degree in Pharmacy, Science, or related disciplines with experience in GCP/PV auditing.
- Job Title: Senior Executive – Medical Quality Affairs
- Location: Mumbai, Maharashtra
About The Company
Alkem Laboratories Limited is a leading Indian multinational pharmaceutical company headquartered in Mumbai. The company develops, manufactures, and markets pharmaceutical generics, formulations, and nutraceutical products across India and more than 50 global markets. Through strong research capabilities, quality standards, and regulatory compliance practices, Alkem continues to strengthen its presence in the global pharmaceutical industry.
Job Description
Alkem Careers is hiring for a Medical Affairs Job focused on optimizing Quality Assurance functions for Pharmacovigilance (PV) and Clinical Trial (CT) activities. The selected candidate will support audit management, regulatory compliance, SOP development, risk-based assessments, and CAPA implementation to ensure adherence to global guidelines and industry standards.
Key Responsibilities
- Optimization of the Quality Assurance function, ensuring compliance with internal procedures and regulatory standards.
- Development of policies/SOPs for quality assurance activities of PV and CT.
- Creation of a risk-based strategic and tactical audit plan.
- Conducting internal PV system audits and ensuring compliance with regulations.
- Planning and conducting audits of clinical research teams and investigator sites.
- Facilitating timely PV and CT audit responses and evaluating corrective actions.
- Supporting global inspection activities in collaboration with Corporate Quality Assurance.
- Assisting in the preparation and follow-up of audits from licensing partners.
- Ensuring timely completion of reports and corrective actions as mandated.
Eligibility Criteria
- Education: Master’s degree or equivalent in Pharmacy, Science, or a similar field.
- Experience: 2-5 years of experience in a Pharmaceutical or CRO setting. Mandatory GCP/PV auditing experience.
Required Skills
- Pharmacovigilance (PV) Quality Assurance
- Clinical Trial (CT) Auditing
- GCP Compliance
- Regulatory Guidelines Knowledge
- SOP Development & Review
- Risk-Based Audit Planning
- CAPA Management
- Audit Response Management
- Quality Management Systems (QMS)
- ICH Guidelines Understanding
Why Join Alkem Laboratories?
Joining Alkem Careers provides an opportunity to work with one of India’s leading pharmaceutical companies and contribute to global healthcare through quality assurance, regulatory compliance, and patient safety initiatives. This Medical Affairs Job offers professionals a platform to strengthen their expertise in pharmacovigilance, clinical research, and pharmaceutical quality systems.
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