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Project Details

Consultant - Quality and Investigation (OOS/OOT)

An Indian biopharmaceutical company

 Bangalore

Posted on:  10/09/2019

Cinque Terre

Starts on:  23/09/2019

BROAD CATEGORY

Manufacturing/Operations

SUB CATEGORY

Manufacturing oversight, Quality assurance, Environment, Health and Safety, Process Engineering / Process excellence,

INDUSTRY

Biotechnology & Medical Research

Company Details

An Indian biopharmaceutical company manufacturing generic active pharmaceutical ingredients that are sold in over 120 countries across the globe

Assignment Details

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.

Skills Required

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.

Assignment Duration

6 month(s)

Capacity Required

Full Time

No. of Positions

1

Nature of Work

On-Site

Profile Requirements

Experience: 10+ years

Qualification: Graduate

fleXpertise required

pharmaceutical OOS/OOTInvestigationslife sciencesinvestigation of deviationsQualitybiopharmaceutical medical device

ESTIMATED BUDGET (Monthly)

-

 

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