JOB VACANCY CAREER OPPORTUNITY JOBS CAREER JOB OPPORTUNITY JOB VACANCIES CAREER OPPORTUNITIES
Kotra Pharma (M) Sdn. Bhd is a wholly owned subsidiary of Kotra Indutries Berhard, a company listed on the Kuala Lumpur Stock Exchange. KPM is one of Malaysia’s leading pharmaceutical manufacturer. As a result of the company’s expansion plans, we are looking for qualified candidates with excellent organization skill, resourceful, independent and good command of English to join us in the following positions:
PHARMACEUTICAL FORMULATOR
(SENIOR FORMULATION SCIENTISTS AND RESEARCH ASSOCIATES) (2 POSITIONS)
JOB SCOPE:
* Development of small volume parenterals and oral solid dosage forms in various therapeutic classes, covering the following aspects: * Development and formulation including product quality plans * Design of experiments, establishing and executing stability & validation programs * Sourcing and evaluation of new API’s and excipients * Pilot and scale-up to commercial batch sizes * Conversant with requirements of the EMEA/USFDA
REQUIREMENTS:
Degree or Post Graduate in Pharmaceutical Science with minimum 5 years experiences in a pharmaceutical and manufacturing environment.
QUALITY ENGINEER
Position A (1 POSITION): WATER SYSTEM & PHARMACEUTICAL STEAM
Position B (1 POSITION): HVAC & MEDICINAL GASSES
Position C (1 POSITION): STERILE PROCESS VALIDATION
Position D (1 POSITION); COMPUTER VALIDATION
JOB SCOPE:
POSITION A & B * Responsible for all matters pertaining to HVAC systems in a pharmaceutical manufacturing setting.
POSITION C * Responsible for all the development and maintenance of quality improvement processes in alignment with the Company’s objectives and in accordance with FDA Code of Federal Regulations and other applicable regulatory regulatory requirements. * Responsible of to facilitates the supplier certification program to ensure that quality systems used by our certified suppliers will enables us to consistently receive components, which meet our documented requirements. * To recommend process improvements utilizing Quality tools (DOE’s, SPC, FMEA, etc) using a “hands on” approach in the proactive manufacturing environment, providing responsive and effective statistical analysis of data in support of product lines.
POSITION D * Responsible for IT Quality, Security and Compliance (QSC) * Responsible of to perform and provide expertise in the department, coordination and execution of IT infrastructure qualification and computer systems validation. * To work closely with the IT Department and members from other business units to execute a risk-based IT systems qualification and validation approach based on the company’s system development lifecycle * To develop and document User, Functional and Design requirements; Installation, Operational and Performance Qualification; acceptance criteria; Standard Operating Procedures; requirements traceability, Infrastructure Qualification and change control.
REQUIREMENTS
POSITION A & B * Degree in Chemical Engineering, Pharmacy, Industrial Pharmacy or related with minimum 5 years experience in pharmaceutical manufacturing preferably in sterile/aseptic manufacturing in a medium or large size company working with HVAC and plant utility systems to support manufacturing operations
POSITION C * Degree in Science, Engineering or related with minimum 5 years experience in a pharmaceutical manufacturing environment
POSITION D * Degree in Computer Science, Information Technology or related industrial experience with minimum 5 years IT experience in a pharmaceutical manufacturing environment
Package range : USD 4,875 – USD 19,500 per annum depending on qualification and professional experience.
Short-listed candidates will be notified
Interested candidates are invited to submit a detailed resume ASAP via e-mail with a recent photograph to hr@kotrapharma.com
For more info visit us : http://www.kotrapharma.com/ and http://www.appeton.com/
Kotra Pharma (M) Sdn. Bhd is a wholly owned subsidiary of Kotra Indutries Berhard, a company listed on the Kuala Lumpur Stock Exchange. KPM is one of Malaysia’s leading pharmaceutical manufacturer. As a result of the company’s expansion plans, we are looking for qualified candidates with excellent organization skill, resourceful, independent and good command of English to join us in the following positions:
PHARMACEUTICAL FORMULATOR
(SENIOR FORMULATION SCIENTISTS AND RESEARCH ASSOCIATES) (2 POSITIONS)
JOB SCOPE:
* Development of small volume parenterals and oral solid dosage forms in various therapeutic classes, covering the following aspects: * Development and formulation including product quality plans * Design of experiments, establishing and executing stability & validation programs * Sourcing and evaluation of new API’s and excipients * Pilot and scale-up to commercial batch sizes * Conversant with requirements of the EMEA/USFDA
REQUIREMENTS:
Degree or Post Graduate in Pharmaceutical Science with minimum 5 years experiences in a pharmaceutical and manufacturing environment.
QUALITY ENGINEER
Position A (1 POSITION): WATER SYSTEM & PHARMACEUTICAL STEAM
Position B (1 POSITION): HVAC & MEDICINAL GASSES
Position C (1 POSITION): STERILE PROCESS VALIDATION
Position D (1 POSITION); COMPUTER VALIDATION
JOB SCOPE:
POSITION A & B * Responsible for all matters pertaining to HVAC systems in a pharmaceutical manufacturing setting.
POSITION C * Responsible for all the development and maintenance of quality improvement processes in alignment with the Company’s objectives and in accordance with FDA Code of Federal Regulations and other applicable regulatory regulatory requirements. * Responsible of to facilitates the supplier certification program to ensure that quality systems used by our certified suppliers will enables us to consistently receive components, which meet our documented requirements. * To recommend process improvements utilizing Quality tools (DOE’s, SPC, FMEA, etc) using a “hands on” approach in the proactive manufacturing environment, providing responsive and effective statistical analysis of data in support of product lines.
POSITION D * Responsible for IT Quality, Security and Compliance (QSC) * Responsible of to perform and provide expertise in the department, coordination and execution of IT infrastructure qualification and computer systems validation. * To work closely with the IT Department and members from other business units to execute a risk-based IT systems qualification and validation approach based on the company’s system development lifecycle * To develop and document User, Functional and Design requirements; Installation, Operational and Performance Qualification; acceptance criteria; Standard Operating Procedures; requirements traceability, Infrastructure Qualification and change control.
REQUIREMENTS
POSITION A & B * Degree in Chemical Engineering, Pharmacy, Industrial Pharmacy or related with minimum 5 years experience in pharmaceutical manufacturing preferably in sterile/aseptic manufacturing in a medium or large size company working with HVAC and plant utility systems to support manufacturing operations
POSITION C * Degree in Science, Engineering or related with minimum 5 years experience in a pharmaceutical manufacturing environment
POSITION D * Degree in Computer Science, Information Technology or related industrial experience with minimum 5 years IT experience in a pharmaceutical manufacturing environment
Package range : USD 4,875 – USD 19,500 per annum depending on qualification and professional experience.
Short-listed candidates will be notified
Interested candidates are invited to submit a detailed resume ASAP via e-mail with a recent photograph to hr@kotrapharma.com
For more info visit us : http://www.kotrapharma.com/ and http://www.appeton.com/
