Senior Manager Quality Control

Senior Manager Quality Control:

Job Overview:

To plan, direct and oversee and control the activities of
quality control department at a pharmaceuticals manufacturing site located in
Kizad, Abu Dhabi while ensuring deliverables meet defined quality standards and
all connected activities are in compliance with in-house procedures and cGMPs.

Responsibilities

1.Ensure compliance to national/international regulatory
requirements with current Good Laboratory Practice.

2.Manage, plan and direct the quality control and
microbiology laboratories to ensure lab testing provide the highest quality
analytical support to manufacturing while ensuring compliance with protocols,
cGMP and safety regulations.

3.Direct the work activities of the raw material, packaging
materials, in-process and finished product and stability studies to ensure that
testing is executed in a timely and compliant manner.

4.Review and investigate all laboratory data that is out of
trend and OOS.

5.Review and approve protocols and reports such as method
validation, method transfer, process validation and stability studies.

6.Report any risks to compliance or product quality to Head
of Quality.

7.Participate in all OOS investigation, identify root cause
and implement corrective action.

8.Review, assessment of all change controls, deviations, CAPA
that arise from quality control laboratory.

9.Ensure all SOP are initiated, reviewed, approved and
implemented as per the documented process.

10.Participate Product Quality Reviews, provide data and
documentation for all products in accordance with SOP.

11.SOP, laboratory records and other related documentation as
assigned meeting the requirements of data integrity and governance.

12.Provide leadership, management, evaluation and training of
all laboratory employees for them to carry out their duties.

13.Co-ordinate for the purchase of laboratory equipment’s,
standards, chemicals from reputable suppliers for testing in the laboratory.

14.Preparation of CAPEX and OPEX for Quality Control.

15.Appointments of qualified staff that meet the requirements
for positions within the laboratory.

16.Participation in all internal and external audits and
actioning all relevant corrective action.

17.Participation in all applicable qualification and
validation activities as a member site validation team and lead the
qualification of laboratory equipment.

Desired Qualifications and Experience:

1.Proven experience as a Quality Control Head/Sr. Manager
role in biopharmaceutical/sterile pharmaceutical company.

2.12+ years of experience in regulated environment with about
5 years in managerial role with quality control.

3.Excellent knowledge of quality methodologies and standards.

4.Excellent understanding of data analysis/statistical
methods.

5.Good knowledge of MS Office and databases.

6.Excellent communication skills, fluent in English, both
written and spoken.

7.Good attention to detail and a result driven approach.

8.Good project management skills.

9.Bachelors or Masters in Pharmaceutical Sciences /
Analytical Chemistry/Biotechnology related discipline.

10.Handled stringent regulatory audits such as EU GMP, US
FDA, GCC/SFDA.