Job Highlights
Plan and monitor the quality control activities in the laboratory by reviewing status of batch release and related lab activities to meet the regulatory requirements w.r.t
trigger CAPAs where required in order to ensure effective handling deviations,recall and complaints
Education
B.Sc in Any Specialization
MS/M.Sc(Science) in Any Specialization
Designation & Department: Head - Quality Control @ Palghar
Experience: 14 to 18 year
Location: Mumbai
Job Description
Roles and Responsibilities
Develop the quality development strategy for a plant and monitor its implementation to ensure it meets the business requirements and customer deliverable.
Plan and monitor the quality control activities in the laboratory by reviewing status of batch release and related lab activities to meet the regulatory requirements w.r.t. lead time, quality, service, OTIF and cost.
Provide guidance for continuous improvement initiatives by identifying areas for optimization and facilitate smooth operations.
Identify critical and high-risk non-conformance / issues from review of audit reports and SOPs; trigger CAPAs where required in order to ensure effective handling deviations, recall and complaints.
Monitor the implementation of all laboratory activities as per SOPs to ensure compliance to cGMP, GLP and regulatory requirements.
Drive people development within the quality control function at a plant in order to maximize performance and achieve better control of operations.
Identify and develop the alternate vendors for continuity of the process / operations.
Desired technical skills:
Knowledge of Tablet, Capsule, dry powder
Knowledge of regulatory guidelines (including 21 CFR Part 11) for manufacturing of OSD
Knowledge of investing techniques like fish bone analysis and why-why techniques
Knowledge of instrumentation related to QC
knowledge of data analytical techniques i.e. Parito Charts
Knowledge about equipment & System validation
Knowledge about Instrument and method validation
Knowledge about Pharmacopia ( IP, BP, EP & USP).
Interested candidates having above experience in Pharmaceutical Formulation shall share resume @ hr.careers@blissgvs.com
إرسال تعليق