This is a sample alert
Our client, is looking to engage with Quality and Investigation Manager to support investigation of deviations, OOS/OOT, complaints etc. in line with established QMS procedures.
Key responsibilities include:
1. Assists with coordination, investigation, management, and reporting of issue
investigation and processes to ensure department and site objectives are being met.
2. Coordinate with members within the CFT as well as others outside CFT to
complete required investigations and actions, advise on proper documentation and root cause analysis, and provide oversight on timely completion of activities.
3. Oversee investigation activities associated with internal quality issues and
those associated with deviations, OOS/OOT, complaints etc.
4. Work with owners of deviation, OOS/OOT, complaints etc. to ensure all investigations are conducted in a structured manner towards root cause identification in a timely manner and provide guidance on appropriate CAPA and identifying appropriate actions, to ensure that all activities comply with company procedures and policies.
5. Create or edit investigation procedures and training materials as required. May deliver communication on Quality Issue and investigation training to staff as required.
6. Gather investigation data and provide Quality issue and investigation process metrics to management. Prepare and participate in cross functional Investigation Review Board Meetings to maintain on time completion of investigations. May chair meetings as needed and lead others through influence.
7. Perform other quality and compliance activities as required including supporting audits and inspections.
1. Minimum of 5 years experience in the pharmaceutical / biopharmaceutical industry, medical device, or life sciences required.
2. Knowledge of Quality systems and processes is preferred.
3. Knowledge of investigation processes and experience performing and leading investigation is required. Ability to use various investigation tools is an advantage.
4. Must have demonstrated experience of influencing others to achieve results and be able to prioritize tasks independently.
5. Must have good communication and organisation skills.
An Indian biopharmaceutical company manufacturing generic active pharmaceutical ingredients that are sold in over 120 countries across the globe
Biotechnology & Medical Research
10+ years
1
Build your
skill profile
Strengthen it
with feedback
Determine your
optimal fee level
Apply for matching
projects
Get finalized
Stay Engaged
Agri & Food Processing
Luxury Retail
More than 3000 clients rely on Flexing It today
We host both full-time & part-time projects from top clients for 100+ skill categories. We also help connect experts like you with clients for short consultation calls called Flexperts
You just need to create a ‘boutique firm’ account during the registration process. The rest of the application process remains the same.
Our freelancers fee benchmarking tool, FeeBee helps our freelancers and consultants find out what their peers charged for similar projects. Built on 600K+ verified benchmarks, registered users get unlimited access to it.
As a freelancing platform, we do not provide permanent positions or full-time job to our consultant network.
Flexing It will be involved end to end right from contracts to invoicing. Once you are finalized, your payment details are transparently laid out in your contract terms with your client and our team actively liaises with the client finance team to ensure timely payments.
We do not charge any fee or commission from you. Your fee quote will be paid out to you in full as per your project contract.