Compliance Manager, Ciba Vision

With worlwide headquarters in Atlanta, Ciba Vision is a global leader
in the research, development and manufacturing of optical and
ophthalmic products and services, including contact lenses and lens
care products. Ciba Vision products are available in more than 70
countries worlwide.

We invite suitable candidates to apply for the following position :

Compliance Manager
(Batam)

Responsibilities:

Manage and facilitate the Quality Management System
implementation, standardization and adherence within CIBA VISION Batam
manufacturing in accordance to cGMPs, legal, ISO, regulatory
requirements as well as CIBA and Novartis Quality Manual requirements.
Develop, implement and maintain batch record review and release
process, annual product review, quality management review, CAPA,
non-conformance management and local complaint processes for CIBA
VISION Batam manufacturing.
Provide follow-up to all non-conformances, ensuring development of
actions plan to address issues preventing reoccurrence. This is
inclusive of an effectiveness verification process following
implementation of corrective and preventative actions.
Develop, implement and maintain the internal audit program.
Perform internal audits per an established schedule ensuring all
quality systems are checked on an annual basis.
Develop, implement and maintain the supplier audit program. This
includes the coordination and/or performance of external audits. The
position could include a minimum of 10% travel.
Assist in hosting Regulatory inspections. Responsible for ensuring
all observations are appropriately addressed and compliance review
initiated.
Review audit readiness strategy and oversee preparedness for
regulatory bodies inspections by managing field CAPA's, any regulatory
actions, follow-ups and assisting in product problem resolution.
Responsible for Quality metrics and establishment of follow-up
actions as required in ensuring metrics are maintain within
appropriate parameters.
Responsible for the improvement process associated with the
quality systems to ensure review on a periodic basis continually
increasing compliance as well as staying current or ahead of industry
trends.
Responsible for staying aware of the FDA database and website with
respect to industry changes, challenges and regulatory trends.
Responsible for the review of validation and process changes in
manufacturing to ensure compliance with standards and submissions.
Responsible for the GMP and technical training programs to ensure
they incorporate the required modules to sustain compliance.
Responsible for ensuring data integrity is maintained through
routine audits of quality systems.
Provide leadership, direction and support to the people within QA
departments and ensure they are qualified, achieve a high level of
competence, are motivated and carry out their duties in a safe and
effective manner.
Work with the Quality staff to ensure quality plans are being maintained.

Requirements:

Bachelor in Engineering or Physical Sciences/Chemistry/Physics or
its equivalent.
5 to 7 years Quality Management experience in
pharmaceutical/medical device/health care environment.
Experience in Quality Control, Quality Assurance and Compliance or
Regulatory Affairs.
Knowledge in change control, statistical process control, training
systems and manufacturing process.
Proven knowledge in cGMPs/Regulatory
Affairs/Validation/Laboratory, 21CFR820 and ISO 13485 requirements.
Excellent oral and written communication skills.

Please email your resume to: hr.recruit@cibavision.com,