ResponsibilitiesManager - Quality AssuranceJob Description Candidate should have good communication skill Must have Regulatory Knowledge and audit handling exposure Must have working exposure of Cleaning Validation and respective work area's Must have sound knowledge of Non-sterile dosage forms Having work experience of preparation of Risk Management, Cross-contamination control strategy etc. Handling of Change Management system

Responsibilities Responsible for the preparation and review of quality regulatory NPD and PLCM submissions for various markets (US and Canada) to ensure timely approval. Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets (US and Canada). Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions. Accountable for assessment, coordination and compilation of deficiency responses in a timely manner. Works with other functional areas to resolve issues related to information for regulatory submissions. Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable. Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned). Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers (Review checklist for PLCM/deficiency response, deficiency tracker, submission spreadsheet etc.) and ensure accuracy of information. Co-ordinate with third party manufacturers for document requirement for regulatory submissions. Act as a back-up for team members and support as & when required. Timely communication and follow-up with the respective departments for compilation and submission of PLCM submissions and query responses to meet agreed timeline. Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable). Interact with other applicable departments within Apotex to discuss and provide solutions to regulatory issues and/or problems. Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Integrity, Teamwork, Courage and Innovation Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other relevant duties as assigned.Qualification & ExpeirenceA Graduate/ Post graduate degree in Chemistry, Biology, Pharmacy, Health Sciences or similar. Project Management would be additional advantage. Knowledge, Skills and Abilities: Demonstrated knowledge of the generic new product development process/requirements and compilation of dossier for key international markets such as Europe, GCC-MENA, Australia, New Zealand, LATAM, Mexico, Brazil, Singapore and Malaysia. Must possess knowledge of the technical, quality compliance, and global regulatory requirements.

Responsibilities Initiate Master Manufacturing Records (MMaRs) & Master Packaging Record (MPaRs) Initiate Placebo and Optimization batch record for trails. Initiate Change Controls in QMS Track Wise for New Launch / Site Transfer / Submission batch / SOPs / Formats and commercial batch documents. Ensure QMS Change control closure within the stipulated timeline. Ensure support for timely completion of Investigations for document related deviations and document revision based on CAPA. Initiation of batch documents , SOPs and Formats in Content server. Check Monthly Schedule to ensure document readiness. Ensure all changes are aligned with cGMP regulations and corporate SODs. Perform all work in accordance with established regulatory, compliance and safety requirements. Coordinate with NPL and RA regarding Deficencies from Regulatory Agencies and Clarifix. Develop and maintain effective working relationships with internal and external customers. Works in a safe manner collaborating as a team member to achieve all outcomes. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance and Passion. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies and HR policies. All other relevant duties as assigned.Qualification & ExperienceMinimum Bachelor of Pharmacy / Science or any equivalent degree. Experience Minimum 1 year of experience in GMP regulated pharmaceutical industry.  Knowledge, Skills and Abilities Adequate knowledge in handling QMS Trackwise tool, Content server tool. People management skillset Adherence to cGMP Exhibit Perseverance in all the tasks performed Problem solving skills

Qualification & Experience                         Qualification: BSc/GNM              Experience: 1+ years    

Qualification & Experience                    Qualification: DM/DNB                 Consultant – General Medicine             Qualification : MD(General Medicine)         

Qualification & Experience                   Qualification: B.Pharm / D.Pharm                   Experience: Minimum 1 year         

Qualification & Experience     Experince - Above 1yr (Prf hospital Exp)             Qualification - Diploma              

Qualification & Experience     Experience: Bachelor's Degree                 Qualification: 2 years of hospital experience        

Qualification & Experience             Experience: Bachelor's Degree              Qualification: 2 years of hospital experience     

Qualification & Experience  Qualification: Bachelor's Degree in a Medical Field, Nursing, or Hospital Administration & PG MBA   Experience: Minimum 5 years of experience