Head of Quality-Korangi
GSK
Korangi, Karachi, Karachi
7d ago

Your Responsibilities : Job Purpose*

Job Purpose*

Provide leadership and direction to ensure the highest standards of product quality and compliance with corporate and regulatory standards.

Accountable for the quality of all GSK products released to market. As a member of the Regional Quality Management Team, establish uniformity of best practices throughout the Supply Division.

As a member of the Site Management Team, contribute to the site strategy, customer service, and continues improvement of the site and GMS.

Key Responsibilities (10 bullet points maximum)

Describe the key deliverables to be achieved by the post holder and the ongoing responsibilities of the role

Overall responsibility for effective operation and Performance Management of QA dept. Implement and maintain effective administrative and quality procedures to ensure the QA service is in fulfil cGMP, compliance with GSK and local regulatory requirements.

Ensure the site quality organization is complying with global quality model and sufficient resource, knowledge and expertise is available to assure the site meets its quality commitments.

Accountable for the implementation of the regulatory guideline (GCC, SFDA & ICH), QMS, CAPs and pharmacopoeia, and ensuring compliance of all activities to local SOPs at the site.

Ensuring all quality policies and procedures for manufacturing, packaging, testing, documenting, storing and transporting GSK products are in place and in use, complying with regulatory requirements.

Ensuring all validation activities and compliance requirements are in place to develop and maintain the systems, methods, processes and equipment compiling with QMS and regulatory requirement.

Ensure and monitor all the internal and external products deviation and incidents, been investigated and notify the Site Director and appropriate management groups of significant deficiencies.

Ensure that corrective and preventative actions are taken.

Ensuring audit systems are in place and effectively applied with effective CAPAs to prevent reoccurrences. To participate in L2 and to lead L3 and L4 audits and accountable to develop effective CAPA for each major or critical observation arising from L3 and L4 audit ensure the closure within due date of CAPAs.

Act as Qualified person and overall responsibility for product release process and final release to market.

Ensure the technical capabilities of QA and site staff, and all job competencies are identified, documented and all training needs are defined in their training curricula.

Promote safe-working environment that complies with company EHS requirements.

Chair the Quality Council process within the site and play an active role in other governance committees as required.

Maintain emergency readiness for situations requiring field alert and product recall in the interests of products manufactured to support quality, safety, efficacy and purity.

Prepare a strategic Quality plan and annual objectives, in line with the GMS Strategy; monitor performance and act to ensure that objectives are met.

Establish and maintain a program to provide personal and professional development for the Quality staff, ensuring clarity of goals and objectives and providing regular monitoring and feedback on performance.

Accountable for all quality risks, ensure risks are identified and managed through on the Risk Management System.

Adhere to Safety, Quality and GPS standards and sustain the relevant QA & EHS KPI metrics to achieve Zero Accident, Zero Defect, and Zero Waste and continues improvements.

Ensuring Quality departments CAPEX is adequately planned for and executed.

requirements

Minimum of 10 years management experience and minimum of five years relevant experience which has provided a sound understanding of site, product stream and quality operations.

Thorough understanding of regulatory and legal requirements in respect of both product quality and staff safety.

Knowledge and understanding of pharmaceutical quality management systems.

Knowledge of sterile product manufacturing (preferred)

Provide strong leadership. Strong in decision making and can take stand

Strong verbal and written communication skills.

Skilled in problem solving and decision making.

Competent in the interpretation of data and regulations and the assessment of risk.

Project management.

Strong influencing skills at senior levels.

Good level of English in terms of speaking, writing and reading.

Fair knowledge of EHS, GMP and GLP.

Computer Skills (Word, Excel & Power point).

Basic qualifications :

People Management experience is a must.

Minimum of bachelor degree with majors in Chemistry, Biochemistry or Microbiology

Chemistry or Microbiology

To provide sufficient insight when developing strategy, preparing and implementing tactical plans and making quality and compliance-related decisions.

To ensure thorough understanding of the impact of regulatory compliance in the pharmaceutical manufacturing environment.

Preferred qualifications :

Bachelor degree in pharmacy

Pharmaceutical

To meet regulatory requirements

To provide sufficient insight when developing strategy, preparing and implementing tactical plans and making quality and compliance-related decisions.

To ensure thorough understanding of the impact of regulatory compliance in the pharmaceutical manufacturing environment.

Why GSK? : GSK Pakistan

Contact information :

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

Important notice to Employment businesses / Agencies

GSK does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site.

All employment businesses / agencies are required to contact GSK's commercial and general procurement / human resources department to obtain prior written authorization before referring any candidates to GSK.

The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business / agency and GSK.

In the absence of such written authorization being obtained any actions undertaken by the employment business / agency shall be deemed to have been performed without the consent or contractual agreement of GSK.

GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses / agencies in respect of the vacancies posted on this site.

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