quality control officer in aurangabad

posted
contact
randstad india
position type
contract
apply now

posted
location
aurangabad, haryana
function
Pharma, healthcare & lifesciences
position type
contract
experience
1
reference number
58727
contact
randstad india

job description

quality control officer in aurangabad

Description: 1.1 Perform and co-ordinate Quality Control activities & testing to ensure continuous production of products consistent with established quality & regulatory standards by performing the assigned duties and responsibilities.

2. DUTIES & RESPONSIBILITIES
2.1 Perform QC testing and Finished Goods testing , RM/PM and stability testing in compliance with all applicable regulations and policies, including FDA Safety & Environment.
2.2. Undertake QC testing including documentation and LIMS entries and
all the related activities.
2.3. Operation and handling of GC, HPLC, Instron, Moisture meter, and other basic laboratory instruments.
2.4. To follow clean Room practices & all its related activities.
2.5. Bioburden studies as per sampling plan , sub dose product families sampling and testing.
2.6. Perform product sterility testing.
Controlled Manufacturing Environment monitoring and trending.
Carries out Water testing and trending. Media preparation and its growth promotion testing including documentation. Media inventory management.
Perform duties and activities assigned by supervisor with respect to quality systems. Maintenance of cleaning and disinfection of various microbiological areas.
Microbiology instruments timely calibrations, validations and documentation. Raw material, Packing material and Finish product physical, chemical and microbiological
testing
2.17 Bio-safety, Bio-hazard management.
2.18 Assures that all microbiological activities run in a safe, clean and environmentally sound
manner.
2.19 Carries out duties in compliance with all regulations and guidelines including Food
&Drug Administration (FDA).
2.20 Complies with all company and site policies and procedures.
2.21 Allows all applicable aspects of the site environmental management system.

2.22 LIMS test data entry
2.23 Compliance & Training
2.23.1 Observes & promotes all regulatory requirements as defined per applicable regulations,
rules & procedures established by the Company, and notified any violation or deviation to
the immediate supervisor or appropriate authority.
2.23.2 Complies with all training requirements to perform duties of the job.
2.23.3 Ensure adherence/compliance to Records Management policies and procedures, as
applicable.


4. EDUCATION/EXPERIENCE

4.1 Bachelor of Science / Master of Science.
4.2 Fresher

5. COMPETENCIES
Technical Skills / Behavioral Skills

5.1 Hands on experience and good knowledge of Quality Control laboratory work, microbiology work.

5.2 Excellent analyzing, decision making ability.

5.3 Knowledge of GMP and GLP, regulations.

5.4 Working knowledge of statistics.

5.5 Computer operations' skill set {MS Office, MS Excel}.

5.6 Knowledge of applicable laws and regulations.

5.7 Ability to initiate, explain and sell innovative thought process and ideas.

5.8 Documentation in line with regulatory requirements.

skills

Quality control

qualification

Any