Client: Leading Group Pharmaceutical Company having Formulations, API, Biologics Business with 30000 Cr Turnover
Role Overview
We are seeking a highly skilled Quality Control Professional to oversee testing, compliance, and release activities for dermatology product lines. The role requires strong knowledge of USFDA regulations, GMP practices, and proven ability to lead and mentor a team in a fast-paced pharmaceutical environment.
Key Responsibilities
Conduct and supervise analytical testing of raw materials, in-process samples, and finished derma products (Ointment, Cream, Gel, Lotions).
Ensure strict adherence to USFDA, GMP, and GLP guidelines for all QC operations.
Review and approve SOPs, protocols, and validation documents related to quality control.
Collaborate with cross-functional teams (Production, QA, R&D) to resolve deviations and implement corrective actions.
Lead investigations of OOS/OOT results, ensuring timely closure and regulatory compliance.
Maintain and calibrate laboratory instruments (HPLC, GC, UV, FTIR, etc.).
Prepare and present quality reports to senior management and regulatory auditors.
Drive continuous improvement initiatives in QC processes and documentation.
Mentor and manage a team of QC analysts, fostering a culture of accountability and excellence.
Qualifications
Master's/Bachelor's degree in Pharmaceutical Sciences, Chemistry, or related field.
6-10 years of experience in Quality Control within pharma/derma products, preferably in a USFDA-approved facility.
Strong knowledge of ICH guidelines, USP/EP standards, and regulatory audits.
Hands-on expertise with analytical instruments and modern QC techniques.
Demonstrated team management and leadership skills.
Excellent communication and documentation abilities.
Desired Attributes
Proactive problem solver with attention to detail.
Ability to thrive under regulatory scrutiny and tight timelines.
Strong interpersonal skills to lead diverse teams and collaborate across departments.
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