Manager Resume

SUMMARY:

A goal - driven professional with nearly bout 14 years of experience in Quality Control, Laboratory.
Presently associated with Confidential, Gujrat. as a Manager-1, OOS/OOT investigator in NPQC (New Product Quality Control).
Skilled in determining quality control standards; successfully handled and actively participated in audits like USFDA, WHO, FDA, KFDA, MHRA, Customers Audits, etc.
Experienced in handling Chromatography and Instrumentation section; successfully worked as OOS/OOT, Incidence Investigator as a part of investigatig team.
An excellent communicator and team manager with strong organizational, analytical & problem solving skills
Proven expertise in managing Raw material section, Wet Analysis, In process and intermediate etc.

TECHNICAL SKILLS:

TECHNICAL: HPLC: Waters - 2695 Alliance with millennium & Empower software, Shimadzu LC - 2010C HT with Class-VP Software & Chromeleon Software, Agilent 1100 Series with Chemstation Software Dionex Ultimate 3000, ACC 3000 With Chromeleon Software GC: Agilent 6890 N & 7890 A (Auto Sampler & Headspace) series with Chemstation Software UV/ VIS SPECTROPHOTOMETER: Shimadzu 1601 POLARIMETER: Rudolph Research Analytical Autopol IV Automatic KF Instrument: Metrohm & Mettler Toledo pH Meter: Mettler Toledo. Motic Microscope (Bio vis) Viscometer (LV DV) Density Meter (Anton Paar) Osmometer (Gonotec)

PROFESSIONAL EXPERIENCE:

Confidential

Manager

Responsibilities:

Heading QMS section and Accountable for investigation of any OOS/OOT in NPQC including both Oral and injectable section (Stability department as well as Finished Product).
Accountable to establish the proper corrective action and preventive action based on the root cause.
Handling of OOS/OOT through QMS (Track wise Software).
Using different tools such as Fish bone (6M), 5-Why etc.

Confidential

Quality Control, Team Leader

Responsibilities:

Worked as a Section Head, in the Instrument and GC sections
Spearheading the team of 15 members including Instrument and GC sections
Managing laboratory incident & Out of Specification result
Planning & preparing external & internal audit
Maintaining good laboratory practices and proper handling of laboratory instruments & Chemicals
Ensuring that non-conformances are duly complied with the audit
Handling of Breakdowns / Trouble Shooting of all concern instruments.
Coordinating with Service Engineer for preventive Maintenance/Breakdown

Confidential

QC Executive

Responsibilities:

Worked as a Shift in charge
Responsible for managing in process and raw material department
Responsible for planning, managing of In-process, Intermediate Analysis by classical and instrumental methods
Involved in the process of maintaining & reviewing laboratory related all documents
Handled laboratory incident & Out of Specification result

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