Job Description
My Clients is looking to recruit a number of experienced, highly energetic people to support their pharmaceutical plants worldwide. These roles will provide excellent developmental responsibility and growth, are permanent roles, based out of Mumbai, India.
They are looking to recruit QA and QC professionals with 7+ years’ experience varying from Senior Analyst to Department Manager Level, with an attractive package and relocation expenses consistent with the role.
Job Spec
These positions are responsible for maintaining and managing the Internal Pharmaceutical Quality System (PQS) in both the QA and QC Functions.
The aim is to improve Quality oversight and compliance to relevant regulatory guidelines in the Manufacturing Facilities of our clients.
The individual will be responsible for performing key Quality tasks with respect to commercial products and development projects in all areas of QA and QC, projects being allocated in consideration of the expertise of the individual.
Responsibilities:
- Management of deviations, CAPA’s and change control notifications associated with commercial products.
- Performance and/or Lead for On-Site Investigations across QA, Operations, QC and Supply Chain.
- Management of PQC and SLC (Product Quality Complaints and Service Level Complaints)
- Operation and maintenance of quality documentation system.
- Preparation and delivery of training on Quality related systems, procedures and processes.
- Developing, preparing and compilation of quality metrics for monthly report.
- Coordinating and leading periodic review of the PQS and management review.
- Supporting supplier qualification, external audit and internal quality review.
- Conducting internal audits and/or coordinating the self-inspection program.
- Supporting regulatory submissions.
- Supporting development projects.
- Work directly with other key Company departments to ensure compliance and productive working relationships.
- Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
- Bachelor’s degree in a Science or Engineering Field.
- Minimum 7 years’ experience in a Medical Device, Pharmaceutical or Biopharmaceutical Environment.
- Highly Energetic Individual with a desire to travel and flexibility to respond at short notiveto company requirements at both Indian and International Sites.
- Experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
- Experience with third-party vendor auditing, out of spec investigations, change control.
- Thorough understanding of quality systems and GMPs.
- Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
- Ability to communicate and interact directly with Plant personnel from Operators to Senior Management
- Experience and Direct Participation in FDA/EMEA/ANVISA and other Regulatory Audits
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors.