RCA is a team of experienced professionals from FDA-regulated industries. Our team has navigated the front lines in Quality, Regulatory Affairs, Operations, Manufacturing and R&D. Not only does RCA understand the complexities of running a life science business, we can also negotiate the difficult demands of remediation and compliance with insight, hindsight and the clear advantage of our unique expertise and experience.
Post: Quality Specialist: Supporting Analytical Lab QC Testing/Mentoring
Job Description
- Support production/lab activities associated with the re-start of production on-site in India
- 3 – 5 years mid-level consulting experience (or more depending upon position)
- cGMP manufacturing plant support experience: API and/or Finished drug manufacturing (3 years minimum, target 3 – 5 years) (US/EU cGMP API manufacturing floor / lab bench experience preferred)
- Previous Warning Letter or Consent Decree remediation experience for manufacturing facility helpful
- Willingness to work job rotations of 6 weeks on-site at the manufacturing production facility in India with two weeks “off” between rotations. Work minimum of 2 rotations for project.
- Work schedule is 6 days per week and one day off (depending upon shift/production schedule)
- Need to be able to climb stairs for several floors and stand for long periods of time while observing plant activities in real time.
- Need to be a team player within an international team of professionals and have a willingness to be flexible to the client’s changing manufacturing/laboratory priorities and schedules
- Working Conditions/Physical Requirements: The position exists in an office environment within a manufacturing facility that is located on a multi-acre campus. Requires both sitting & standing for long periods of time with occasional stooping, bending, reaching, grasping, etc. May require occasional lifting, carrying, pushing, pulling, of objects up to, but not limited to, 10 lbs. Frequent repetitive motion tasks performed (i.e. computer work/standing). Must work well in team environment and have a can-do attitude to help where needed.
Candidate Profile
- Four year degree in Chemistry/Microbiology, masters degree in technical discipline preferred
- Minimum 4 years of hands-on experience in cGMP production facility supporting QC laboratory testing.
- Experience/exposure of QC production sampling activities
- Bench top experience in analytical chemical testing of raw materials, excipients, API intermediates and/or API finished goods (3 - 5 years experience in QC sampling and testing in wet chemistry/analytical testing using chromatographic analysis/microbiology)
- Strong Bench top experience at mentoring & qualifying chemists in the GMP aspects of analytical chemical testing of raw materials, excipients, API intermediates and/or API finished goods (significant experience in managing / mentoring QC sampling and testing in wet chemistry/analytical testing using chromatographic analysis/microbiology)
- Good documentation practice: A portion of the time will be spent on executing checklists generated for production and laboratory cGMP processes and require legible hand writing and details of supporting back-up data for the checklist entries.
- Experience with Compendial testing a plus
- Strong working knowledge of cGMP Practices in FDA approved laboratory testing facility
- Significant experience in analytical method development/validation activities
- Practical understanding and experience resolving analytical testing deviations (OOT, OOS, etc.)/root cause investigations and effective CAPA’s
- Experience with mentoring / hands-on laboratory analyst in cGMP, GLP, GDP work
- Proven track record with mentoring / hands-on laboratory analyst in cGMP, GDP work
- Previous experience with analytical specification development is a plusThis project has 24/7 coverage expectation, work shifts can vary to support production needs
- Strong interpersonal skills required: communication, ability to multi-task and work in a team environment.
Additional Information:
Location: India
Functional Area: QC
Job Code: 214
Industry Type: Pharma/ Biotech/Clinical Research
Employment Type: Full Time
Job Type: Regular
End Date: 15th October, 2014
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