Quality Assurance Manager

Job Purpose

Ensure Quality Compliance in Manufacturing and Quality Operations to ensure quality products with respect to GSK and Regulatory specifications are produced and released to the market, and support in improvement of Quality processes at site.

Education, Experience & Skills

• Pharm D

• 7 Years with 5 years of experience in Quality Control Lab testing

• Excellent Team management & communication skills.

Key Responsibilities

Completes Operational Requirements:

• Ensure products are manufactured with respect to specifications and maintain data integrity, GMP/GDP requirements during the manufacturing process in all shifts.

• Manage Operational Quality key objectives and routine tasks for timely completion as per GSK requirements to ensure smooth function in the department

• Ensure batch release at right time by reviewing all batch related documents on time.

• Ensuring implementation of GMP/GDP, SOPs and group policies.

• Follow up for timely closure of deviations and Customer complaints by assessing and approve deviation records, associated corrective and preventative actions (CAPA), effectiveness and deviation trending

Maintain Documents and Records

• Manage all documents such as Standard Operating procedures, Batch dossiers, responding to internal and external customer for information and technical requirements

• Manage all internal and external Quality agreements.

• Review of imported products documents for release.

• Ensure you keep the documents and keep samples in the storeroom.

• Providing weekly and monthly reports

Support Audit and Investigation Process

• Work with production for identification of corrective and Preventive Actions related with the deviations and Customer Complaints and ensure timely completion of investigations and actions.

• Conducting Self Inspection Audit of the department and participating in Level II & III audit.

Maintain Customer Complaint System:

• Handling of complaints in a timely & professional manner to ensure reporting of Customer complaints within specified period

Approval of SPS, BMR and BPR

• Approval of SPS, BMR and BPR. Maintaining of product history register.

Conducting SQC Meeting.

• Prepare Site Quality Council presentation, Conduct SQC on monthly basis, and prepare

• SQC minutes and circulate at site, prepare SQC tracker, take actions and follow up for compliance.

Monthly reporting preparation

• Monthly reporting of investigations and training and anomalies (document errors).

Certificate of Analysis

• Supervise on time submission of Certificate of Analysis.

Periodic Product Review

• To ensure on-time completion of PPR as per schedule.

Scope of Accountability

• Completes Operational Requirements

• Maintain Documents and Records

• Support Audit and Investigation Process.

• Approval of SPS, BMR and BPR

• Conducting SQC Meeting.

• Monthly reporting preparation

• Certificate of Analysis

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, its also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves - feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

Contact information:

You may apply for this position online by selecting the Apply now button.

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Information :

• Company : GSK
• Position : Quality Assurance Manager
• Location : Karachi
• Country : PK