Job Description
B. Pharma / M. Pharma with 5-7 years experience of Injectable Production QMS (Deviation investigation Drafting, Change control, OOS/OOT investigation handling, etc) documentation. Preferably from USFDA approved reputed company.
Qualifications
- To follow the safety rules in the premises according to the company norms. To handle Quality Management Documents like Change Control, Deviation etc
- To prepare Failure Investigation Reports against Quality impacting deviations, Out-of- Specifications and Non-Conformances.
- To ensure investigations are evaluated and closed out in a timely manner to meet business needs.
- Responsible for cGMP compliance related to CAPA implementation and to ensure the timely closure of CAPA.
- To review, develop and introduce systems, practices and cultural changes that enable the department to meet business demands within agreed time frames and expected GXP standards.
- To perform risk analysis for different process or procedures and implement necessary mitigation plans through Quality Risk Management (QRM).
- To provide direct input or coaching support for other functional groups in investigations.
- To conduct internal audits as per laid down schedule with different function.
- To prepare and review of Standard Operating Procedures / Protocols.
- To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record / Standard Operating Procedure / Protocol and initiation of corrective actions.
- To participate in Regulatory & Customer Audits.
- To evaluate & investigate Market complaints.
- To provide training to subordinates for different processes / procedures.
- Responsible for intra and inter coordination with different functions.
- To prepare BMR and BPR.
- Timely completion of allotted Sop s training.
- Preparation and periodic revision of SOPs related to QMS area.
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instructions and guidance.
About Us
Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.
About The Team
The
Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.
Key Roles That The Human Resources Team Performs
Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.
Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.
Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.
Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.
Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.
