head - qc in pune

posted
contact
randstad india
position type
permanent
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posted
location
pune, maharashtra
function
Pharma, healthcare & lifesciences
position type
permanent
experience
10-15
reference number
60045
contact
randstad india

job description

head - qc in pune

There is an urgent job opening in an established Company which is in the field of Contract Manufacturing & Contract R&D. 
Designation: Head - QC Qualification: M.Sc. Chemistry / PhD in Organic Chemistry (PhD candidate more preferred)
Experience: About 15 years (At least 3 years at a level of Sr. Manager level) in  API, CRAM facility with good regulatory environment.

Responsibilities:Responsible for all QC, ADL batch release process.
 Lead the team of 40+ QC/ADL staff for routine activity and lead department in Quality audits.
 Expert in micro planning of sample management and analysis within available capacity.
 Knowledgeable on review and approval of QMS documents, OOS/OOT/Lab
Event/Deviation/Change Control/CAPA/Action Items/ Extension Process & on time closure of all QMS records for Quality Control Laboratory supporting documents as a secondary check.
 Responsible to check the audit trail for all 21 CFR instruments in Quality control laboratory.
 Knowledge on Laboratory standards/Chemicals which are using in Quality control department.
 Hands on analytical instruments like HPLC, GC, UV, IR and QC Equipment/Instrument usage, troubleshooting and calibrations.
 Knowledge of NMR, Mass interpretation and impurity profiling.
 Hands on analytical method development,
 To verify the protocols/reports for new product launch/site transfer/Analytical method transfer/Analytical method validation.
 To verify the procedural gaps, practices and controls with respective standards/guidelines.
 To create awareness trainings in Quality Control Department with respective procedures.
 Knowledge on Laboratory safety and personnel protective equipment
 To maintain documents as per GLP and GDP requirements
 Handling of QC Manpower, shift schedule,
 To identify departmental strength and equipment requirement time to time and present Capex and Opex.
 Experience in ISO 9001, ISO 14001 will be added advantages.

skills

QC, ADL

qualification

PHD