31 Jul
|
Pramukh Staffing
|
Palanpur
31 Jul
Pramukh Staffing
Palanpur
Job Description: Job Description:
We are hiring an experienced QC skilled to lead and manage quality control operations in our API manufacturing unit. The Assistant Manager will be responsible for supervising analytical activities, ensuring regulatory compliance, handling audits, and supporting continuous improvement initiatives.
Key Responsibilities:
Supervise routine analysis of raw materials, intermediates, and finished APIs
Review and approve analytical documents (STP, SOPs, COAs, protocols, etc.)
Ensure compliance with cGMP, ICH, and regulatory guidelines (USFDA, WHO, EU GMP)
Manage HPLC, GC, UV, FTIR, and other analytical instruments
Lead investigations of OOS, OOT, deviations, and lab incidents
Oversee method validation, calibration, and stability studies
Coordinate with QA, Production,
and RA teams for smooth operations
Train and mentor QC analysts and junior staff
Prepare for and participate in regulatory and customer audits
Maintain lab data integrity and ensure adherence to ALCOA+ principles
Key Skills & Competencies:
In-depth knowledge of analytical techniques (HPLC, GC, etc.)
Solid understanding of cGMP and global regulatory requirements
Experience in API industry QC operations
Proficiency in data review and laboratory documentation
Team leadership and cross-functional coordination
Exposure to software like LIMS, Empower, or Chromeleon is a plus
📌 Assistant Manager Qc Palanpur
🏢 Pramukh Staffing
📍 Palanpur