Open position
- REGULATORY COMPLIANCE OFFICER (Piscataway, NJ): (multiple pos.)
assist with controls, deviations, incidents, nonconformances (PD/PK/WH); perform reviews/updates of SOPs; ensure adherence to SOP, protocols, batch records; conduct regulatory audits; maintain quality management systems. Masters (or foreign equiv. deg.) in Regulatory Affairs, Pharmaceutical Science, rel. + knowledge of cGMP compliance, ANDA preparation/submissions, review/analysis of raw materials, defect root-cause analysis, FDA regulatory compliance.
Send resume: APPCO Pharma LLC, 262 Old New Brunswick Rd., Suite N, Piscataway, NJ 08854.
Appco Pharma is looking for Compression, Granulation/Fluid Bed Dryers, Blending & Coating Equipment's Operators in 2nd, 3rd shifts
Job Description
High School Graduate or GED Equivalent (we have to list both, since they are equivalent), should able to read and write English.
REQUIRED:
Educational background: High School Graduate
Work Experience: Prefer minimum Five (5) year of work experience in a pharmaceutical manufacturing environment.
Skills, knowledge and abilities: - A demonstrated ability to follow written instructions precisely and perform basic math calculations is required.
Should have an understanding/knowledge of cGMP, safety criteria or the ability to learn.
Benefits:
Competetive Salary, 401K Plan, Health Insurance, Paid & Sick Leaves
Email Application to info@appcopharma.com or
send resumes to
Human Resource
Appco Pharma LLC
262 Old Newbrunswick Road, Suite N,
Piscataway, NJ 08854
Job Description
- To be able to Setup, assemble & disassemble, clean Tablet compression machines like Eliza Press, Kikusui - Libra, Sejong and Killian
- Good experience on operation of Glatt FBD equipment, V-Blenders and also Different Coating Equipment's.
- Clean Manufacturing Room after the completion of product run as per SOP.
- Make any machine adjustments necessary during the batch run as required.
- Able to trouble shoot equipment's for run, including startup of batch and obtaining all specifications as per instruction in Production Batch Record.
- Document all set up and cleaning in the log book and other pertinent paperwork.
- Perform any and all additional tasks relating to the operation of the manufacturing department as requested.
- Follow company policies, cGMP's and Standard Operating Procedures.
- Physical Work Activities and Exposure:
- Work is regularly performed inside in a manufacturing environment.
- Exposure to dust, odor, noise, and fumes.
- The noise level is usually moderate.
- Must frequently lift and/or move up to 50 pounds and occasionally lift and/or move up to 75 pounds.
- Frequent sitting, talking, or hearing.
- Use hands to finger, handle, feel, or operate objects or controls.
- Walk short distances. Clean and/or disassemble press after the completion of tablet run.
High School Graduate or GED Equivalent (we have to list both, since they are equivalent), should able to read and write English.
REQUIRED:
Educational background: High School Graduate
Work Experience: Prefer minimum Five (5) year of work experience in a pharmaceutical manufacturing environment.
Skills, knowledge and abilities: - A demonstrated ability to follow written instructions precisely and perform basic math calculations is required.
Should have an understanding/knowledge of cGMP, safety criteria or the ability to learn.
Benefits:
Competetive Salary, 401K Plan, Health Insurance, Paid & Sick Leaves
Email Application to info@appcopharma.com or
send resumes to
Human Resource
Appco Pharma LLC
262 Old Newbrunswick Road, Suite N,
Piscataway, NJ 08854