Quality Control Manager

Nazish Babar

Flat # B*, Prime Centre, Federal B. Area, Block-7, Karachi

Cell No. +92-342-*******

ad5yq4@r.postjobfree.com

Profile:

An ambitious, analytical & creative Quality Control & Quality Compliance Professional with more than 10-years’ experience.

Having hands-on experience in different quality management functions including analysis, material & product release, equipment calibration, cGMP compliance,data integrity, regulatory compliance, national and international audit reports, deviation, CAPA, change controls etc.

Highly flexible, adaptable and excellent team player; adept at multi-tasking and meeting tight timelines.

Motivated, committed & self-initiator who endures to succeed in challenging environment.

CAREER ACCOMPLISHMENTS:

Getz Pharma (Pvt.) Limited

November 2011 – PRESENT

Current Designation: Associate Manager Quality Control

Presently working as Associate Manager QC - deputed to Getz Pharma Unit-II (Cephalosporin’s Facility) since July 2022. Involved in development of Lab including various core functions of QC Lab such as Lab & Equipment Qualification, Volumetric and Test Solutions Program, Inventory management, reference and working standard program, development of raw materials, which will be followed by management of raw material release including all core functions of the lab.

Also involved in management of area of Semi-Finished Goods and Finished Goods for the execution and planning of analysis and on time releasing of products as per defined procedures and cGMP standards. Dealing with queries related to regulatory management to meet Compliance requirements by regulatory authorities.

Prime Responsibilities:

Planning & Execution of Raw Materials & Semi-Finished and Finished Products:

Ensure planning and execution of analysis of incoming raw materials & Semi-Finished and finished goods received in quality control laboratory and to ensure on time release within lead-time as per GMP standards and defined procedures.

cGMP Compliance & Documentation:

Maintain and ensure good documentation practices and compliance requirements as per international and WHO standards. Prepare of Standard operating procedures, specifications and design controlled formats for execution of laboratory functions as per cGMP standards and ALCOA+ principles of data integrity.

Regulatory Compliance:

Support regulatory and compliance in responding queries from local and international regulatory authorities, also provide technical information to regulatory management department to comply international and regulatory requirement and standards.

QMS Functions

Ensure core functions of Quality Management system by making change controls, deviations, risk assessments, corrective and preventive action reports related to Quality Control functions and make audit reports in coordination with Quality Assurance and Compliance Department.

Audit and Compliance:

Handled various national and international audits and inspections successfully which includes WHO, PICS, ISO 17025 - Lab Accreditation and other international audits which pertains to Kenya, Sudan, Tanzania etc.

Responsible for preparation of audit reports and corrective and preventive action (CAPA) in coordination with Quality Assurance and Compliance department, in order to respond adequately to close the audit findings.

Equipment’s Handling, Calibration & Maintenance:

Capable of handling sophisticated QC equipment’s, their operation, calibration, preventive maintenance, qualification and verification activities such as HPLCs, dissolution apparatus, UV spectrophotometer, pH meter, disintegration tester, weighing balances etc.

Environmental Aspects of Quality Control Laboratory:

Identified environmental aspects of Quality Control Laboratory and hazard identification, performed detailed risk assessment to ensure Environment, Health and Safety to meet ISO standards.

Training and Development:

To develop technical and soft skills of lab personnel’s by conducting lectures and trainings on large scale for learning and growth of employees w.r.t Quality Control core functions, audit and compliance.

Other Core Responsibilities:

To ensure and execute laboratory investigations of out of specification and out of trend results as per defined protocols and standard procedures.

To ensure annual budget activities of the department including Operational expense, Capital expense, building maintenance and other expenses by implementing lean sigma concept to meet cost effectiveness in assets and company expenditure.

To ensure inventory management of Lab Chemicals, HPLC Columns and other equipment accessories.

Awards & Recognitions:

•Deputed as Lab Incharge in Getz Pharma Unit-II ( Cephalosporins Facility) in July,2022.

•Received Awareness & Implementation session to ISO 17025:2017 in 2021.

•Promoted as Associate Manager Quality Control (H-08 Grade) in 2020.

•Promoted as Assistant Manager Quality Control (H-07 Grade) in 2018.

•Received International training certificate on USP calibration standards of Weighing Balances.

•Promoted as Assistant Manager Quality Control (H-06 Grade) in 2016.

•Promoted as Senior Executive Quality Control (H-05 Grade) in 2015.

•Received International training on Shimadzu HPLC from Singapore in 2015.

•Promoted as Executive Quality Control (H-04 Grade) in 2014.

Novins International Private Limited

April 2010 – November 2011

Quality Assurance Officer

Job Responsibilities:

To ensure good and safe practices in Quality Assurance.

To collect raw material, packaging material and finished goods samples as per defined procedures.

Sample management of stability testing as per stability protocols.

To prepare Standard operating procedures of the department.

To perform batch record audit.

To check and maintain QA record.

To assist QA Manager in Regulatory affairs.

To perform in process checks in production manufacturing and packaging departments.

EDUCATIONAL CREDENTIAL:

•Pharm-D from Karachi University

•Higher Secondary School Certificate (Pre-Medical)

•Secondary School Certificate (Biology)

PERSONAL INFORMATION:

•Husband’s Name: Babar Ali

•Date of Birth: April 02, 1987

•CNIC No.: 42201-8620730-8

•Nationality: Pakistani

•Marital Status: Married

REFERENCES:

Will be furnished on request

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